Annex to Chapter 6.15: Depression in Young People and the Elderly
Priority Medicines for Europe and the World
"A Public Health Approach to Innovation"
Background Paper for Review
Annex to
Depression in Young People and the Elderly
By Eduardo Sabaté
10 August 2004
Please send comments to:
Dr. Eduardo Sabaté: esabate@post.harvard.edu
Dr. Richard Laing: laingr@who.int
Anx_6.15-1
Annex to Chapter 6.15: Depression in Young People and the Elderly
Inventory of Clinical Trials already in the Market91
Trial
Condition
Study Design
Intervention
Mechanism
BIOLOGICAL
BASIC RESEARCH
Use of
Complementary and
Alternative Medicine
Among Older Mexican
Americans
Arthritis; Diabetes
Mellitus; Fractures;
Hypertension;
Depression; Urinary
Incontinence
65+
Observational
1993-2000
Adolescence, Puberty, Mood Disorder;
and Emotion
Neurobehavioral
Regulation
Manifestation;
Healthy
9-17 & 20-40
Observational
2001
fMRI
The Psychobiology of
Childhood
Temperament
Mood Disorders;
Anxiety Disorders;
Adolescents
9-16
Observational
2003-?
fMRI
Reward-Related
Processes and Brain
Function
Depression; Anxiety
Disorders; Healthy
9-17 + 20-40
Observational/Nat
ural History
Development data
Reward-Related
Processes and Brain
Function
Depression; Anxiety
Disorders; Healthy
9-17 + 20-40
Observational/Nat
ural History
Development data
Genetics of
Fibromyalgia
Fibromyalgia; Irritable 12+
Bowel Syndrome;
Observational
Chronic Fatigue
Syndrome; Depression
Genetic Mapping
Brain Function in
Mentally Ill
Adolescents
Healthy;
Posttraumatic Stress
Disorder; Major
Depressive Disorder
functional MRI
Epidemiology of
Cardiovascular Risk
Factors in Women
(Healthy Women
Study)
Cardiovascular
Observational
Diseases; Heart
1983-2007
Diseases; Depression;
Carotid Artery
Diseases; Menopausal
Complaints;
Menopause
9-17
Observational
Study
2001-?
Behavioral and
Cardiovascular
Immunological Factors Diseases; Coronary
in Coronary Disease
Disease; Heart
Diseases; Depression
Observational
2001-2006
Mechanisms Linking
Depression to
Cardiovascular Risk
Depression;
Cardiovascular
Diseases; Heart
Diseases
Age?
Co-twins
retrospective
2001-2005
University of North
Carolina Alumni
Heart Study
Cardiovascular
Diseases; Heart
Diseases; Coronary
Disease; Depression
Observational
1996-2005
Anx_6.15-2
Relation CVD and
depression
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Hostility, Depression,
Social Environment
and CHD Risk
Condition
Cardiovascular
Diseases; Coronary
Disease; Heart
Diseases; Depression
Study Design
Intervention
Mechanism
Observational
1997-2004
FMRI Study of
Performance During a
Probabilistic Reversal
Learning Task in
Depression
18-50
Observational
study
2004
Neurocardiac Control
in Major Depression
Any
Observational
2004-?
combine H (2) (15) O
positron emission
tomography (PET) and
analysis of heart rate
variability (HRV)
Anxiety and Vagal
Cardiovascular
Observational
Control of the Heart in Diseases; Coronary
1999-2004
Coronary Disease
Disease; Depression;
Heart Diseases; Death,
Sudden, Cardiac;
Arrhythmia
Neuroanatomy of
Major Depressive
Emotion Regulation in Disorder
Major Depressive
Disorder
18-50
Observational
2003
FMRI
Brain Regulation of
Emotions in People
with Depression and
Anhedonia
18-50
Observational
2003
FMRI
Effect of Acetylcholine Mood Disorders
on Thinking and
Emotion in Individuals
with Mood Disorders
18-45
Observational
2003
Scopolamine
fMRI
Framingham
Offspring Study:
Psychosocial Risk
Factors
Cardiovascular
Diseases; Coronary
Disease; Heart
Diseases; Depression;
Atrial Fibrillation
Observational
Study
2001-2003
Brain Imaging in
Depression
Depression; Bipolar
Disorder
18-50
Observational
2002-2003
Dynamics of Leptin
and Endocrine
Function
Healthy; Involutional
Depression
Observational
1996-2002
Effects of
Hydrocortisone in
Patients with PostTraumatic Stress
Disorder
Post-Traumatic Stress
Disorders; Healthy
18-60
Observational
2002-?
Major Depressive
Disorder
Anx_6.15-3
Drug: [O-15] Water
Drug: [F-18] FP-TZTP
Leptin as hypothalamus
regulator and
determinant of major
depression
PET Scan
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Brain Chemical
Receptor Effects in
Patients with Panic
Disorder and PostTraumatic Stress
Disorder
Condition
Study Design
Panic Disorder;
Posttraumatic Stress
Disorder; Major
Depressive Disorder
Observational
2001
Do Hostility and Stress Cardiovascular
Predict Cardiovascular Diseases; Coronary
Mortality in MRFIT?
Disease; Heart
Diseases; Depression
Observational
2001
Examination of Brain Mood Disorder
Serotonin Receptors in
Patients with Mood
Disorders
18-60
Observational
Study
2001-?
Progestin
(progesterone-like
hormones) induced
dysphoria (depressed
mood, irritability,
anxiety)
40-65
Observational
1998-2003
Depressive Disorder;
Mood Disorder;
Psychomotor
Agitation
Neuroimaging of St.
Healthy; Mood
John's Wort-Induced
Disorder
Changes of Serotonin
Metabolism in Normal
Subjects
Observational
1999-2002
Intervention
Drug: O15 Water
Drug: FCWAY
Drug: flumazenil
PET Scan
5-HT1A and BZD
receptor function is
abnormal in patients
with PD, PTSD, and
depression.
Stress hormone cortisol
effects on 5-HT1A and
BZD receptors
Drug: 15 O-water
Drug: FCWAY
PET Scan
serotonin 1A (5-HT1A)
receptor function is
abnormal in patients
with mood disorders
Drug: Hypericum (LI160)
Consequences of
Bereavement;
?
Conjugal Bereavement Depressive Disorder; 1997-2002
in Adults
Immunologic Disease;
Mental Disorder;
Sleep Disorder
Effects of Sex
Hormones on
Circadian Rhythm in
Men and Women
Bipolar Disorder;
Circadian Rhythm;
Depressive Disorder
18-45
Observational
1999-2001
Study of the
HypothalmicPituitary-Adrenal
(HPA) Axis and its
Role in Major
Depression
Fatigue Syndrome,
Chronic; Healthy;
Mood Disorders
Any
Observational
1995-2000
Glucocorticoid Effects
on Cellular Cytokine
Release
Depressive Disorder; Any
Fatigue Syndrome,
Observational
Chronic;
1994-2000
Fibromyalgia;
Healthy; Inflammation
Use of Repetitive
Transcranial Magnetic
18-70
Observational
Anx_6.15-4
Mechanism
Repetitive Transcranial
Magnetic Stimulation
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Condition
Stimulation (rTMS) in
Chronic Posttraumatic
Stress Disorder (PTSD)
Study Design
1997-?
Impact of Sleep
Disordered Breathing
in Older Adults
Cardiovascular
Diseases;
Hypertension;
Depression; Sleep
Apnea Syndromes;
Lung Diseases
Males Age?
Observational
1994-1998
Prediction of Quality
of Life in
Cardiovascular
Disease
Cardiovascular
Diseases;
Cerebrovascular
Accident;
Hypertension;
Depression; Heart
Diseases
Observational
1992-1995
The Effect of GnRH on
Pitutitary Hormones
in Menstrual-Cycle
Mood Related
Disorders
Depressive Disorder;
Healthy; Mental
Disorders; Mood
Disorders
18-65
Observational
1988-2000
PerimenopauseRelated Mood and
Behavioral Disorders
Depressive Disorder;
Healthy
40-60
Observational
1988
Study of MenstruallyRegulated Mood and
Behavioral Disorder
Mental Disorder;
Mood Disorder
18-50
Observational
1981
Clinical trials of two
Mood Disorders;
non-drug treatments
Depressive Disorders;
for chronic depression Depression; Chronic
depression;
Nonseasonal
depression
Intervention
Mechanism
(rTMS)
18-65
Device: Bright light box Circadian clock
Randomized, Sing Device: Negative ion
le Blind, Dose
generator
Comparison, Paral
lel
Assignment, Effica
cy Study
The Effects of
Perimenopause;
Hormone Withdrawal Depression
on Mood Symptoms in
Women with
Perimenopausal
Depression
HRT Withdrawal
Serotonin Function
During Depression
Depression,
Involutional; Healthy
18-60
Experimental
Clinical
Physiology
Genetic Mapping
MRI Study of Brain
Activity and Risk for
Depression in
Adolescents
Involutional
Depression; Anxiety
Disorders
10-17
Observational/Nat
ural History
Brain functioning
w/ MRI
Anx_6.15-5
Drug: [O-15] Water
Drug: [F-18] FDG
PET Scan
tryptophan depletion &
central serotonergic
systems
Adolescent under risk
(depressed parents)
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Condition
Study Design
Intervention
Mechanism
Heart Disease Risk
Factors in Major
Depression
Adrenal Gland
Hyperfunction;
Cardiovascular
Disease; Involutional
Depression
18-65
Observational/Nat
ural History
IHD Factors
Genetics of Recurrent
Early-Onset
Depression
Depression
18-70
Observational
Genetic mapping
Genetic Risk Factors
Use of Bone Biopsy to
Better Understand the
Causes of Decreased
Bone Mineral Density
in Depression
Bone Diseases,
Any with OP
Metabolic; Depression, Observational
Involutional;
Osteoporosis
Bone Biopsy for
Histomorphometry
and Analysis of Bone
Marrow
Bone Mineral Density
in Women with Major
Depression
Healthy; Involutional
Depression;
Osteoporosis
non-radioactive
Unknown
calcium isotopes + dual
X-ray absorptiometry
(DEXA) scan
Women's Use of
Alternative Medicine:
A Multiethnic Study
Uterine Fibroids;
18+ Females
Osteoporosis; Urinary Observational
Tract Infection; High 2001-2001
Blood Pressure; Heart
Disease; Arthritis;
Depression;
Headaches
Observational
Diagnostics
Any with OP
Unknown
PSICOLOGICAL
BASIC RESEARCH
Validation and
Exploration of Sleep
and Mood Predictors
Sleep Apnea
Syndromes;
Depression; Lung
Diseases; Sleep
Observational
1995-1999
Major depression and
inflammatory risk
markers for coronary
heart disease
Depression
18-55
Observational
Mediators of Social
Support in Coronary
Disease
Cardiovascular
Observational
Diseases; Coronary
Study
Disease; Heart
1992-1998
Diseases; Myocardial
Infarction; Depression
Interactions of
Depressed Mothers
with Their Infants
Healthy; Depression
Psychosocial
Correlates and Coping
Strategies Associated
with Long-Term
Survival of HIVInfected Children
Acquired
8-18
Immunodeficiency
Observational
Syndrome; Depressive
Disorder; HIV
Infections
Child development
Anx_6.15-6
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Condition
Study Design
Intervention
Mechanism
Study of the
Psychological
Development of
Children of Parents
with and without
Affective Disorders
Bipolar Disorder;
Involutional
Depression; Mood
Disorder
Observational/Nat
ural History
Adolescent under risk
(depressed parents)
Platelet Function in
Patients Treated with
SSRI and non-SSRI
Antidepressants
Depression
18+
Naturalistic
SSRI decrease platelet
serotonin
Major Depressive
Disorder; Depression
12-17yo
Drug: Fluoxetine
SSRI
RCT, Placebo, C/E Behavior: Psychothera
Phase III
py
TECHNOLOGY
CLINICAL
RESEARCH
Treatment for
Adolescents With
Depression Study
(TADS)
Treatment Of Resistant Major Depressive
Depression In
Disorder; Dysthymic
Adolescents (TORDIA) Disorder; Depression
12-18 yo
RCT, Efficacy
Study
Phase III
Drug: fluoxetine
(Prozac)
Drug: venlafaxine
(Effexor XR)
Procedure: Cognitive
Behavioral Therapy
(CBT)
Drug: citalopram
(Celexa)
Optimizing Protocol
SSRI vs Non-SSRI
Clinical Trial of
Memantine for Major
Depression
18-80yo
Safety & Efficacy
Phase III
Memantine HCL
glutamatergic system
Riluzole to Treat Major Depression
Depression
18-70yo
Safety/Efficacy
Phase II
Riluzole
antiglutamatergic and
neuroprotective
properties
Examination of a Soy- Depression
Based Supplement for
Major Depression
18+
RCT
Safety/efficacy
soy isoflavone genistin phytoestrogen and
protein tyrosine kinase
inhibiting properties
Antidepressant
Treatment of AIDS
Related Depression.
18-65yo
RCT
Phase II
Imipramine
hydrochloride
18-75
RCT
Phase IV
Drug: citalopram
Protocol Optimization
Drug: BuproprionSR
Drug: buspirone
Drug: Lithium
Drug: mirtazapine
Drug: nortriptyline
Drug: sertraline
Drug: tranylcypromin
e
Drug: VenlafaxineXR
Depression
Depression
Sequenced Treatment Depression
Alternatives to Relieve
Depression (STAR*D)
Anx_6.15-7
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Condition
Study Design
Intervention
Mechanism
Behavior: Cognitive
Therapy
Drug: T3
(Triiodothyronine)
Preventing the Return Depression
of Depression in
Elderly Patients
60-80
RCT
Phase ?
Nortriptyline
Chronic therapy for
unsustainable remissions
Olanzapine Versus
Active Comparator in
the Treatment of
Depression in Patients
with Schizophrenia
Depression;
Schizophrenia;
Schizoaffective
Disorder
18-60
RCT
Phase IV
Olanzapine and
investigational agent
N/a
Antidepressant
Treatment of
Melancholia in Late
Life
Depression;
Melancholia
60+
RCT
Efficacy & Safety
Drug: Sertraline
Drug: Nortriptyline
SSRI vs TCAs
Clinical Trial of
Estrogen for
Postpartum
Depression
Postpartum
Depression
20-45
RCT
Safety & Efficacy
Phase II
17 beta-estradiol
declining estradiol
secretion
Depression in
Alzheimer's Disease
(DIADS-2)
Alzheimer's Disease;
Depression
All Alzheimer
patients
RCT
Phase III
Drug: sertraline
(Zoloft)
Drug: Placebo
Biological Aspects of
Depression
Depression and
Antidepressant Drugs
21-69
RCT
Drug: paroxatine
Drug: Desipramine
Fluoxetine as a Quit
Smoking Aid for
Depression-Prone
Smokers
18-65
RCT
Phase II
Drug: Fluoxetine
Behavior: Behavioral
group smoking
cessation treatment
Unknown
Depression and Health Depression; Epilepsy
Outcomes in
Refractory Epilepsy
21-75
RCT
Compliance
Phase III
Drug: sertraline
Behavior: cognitive
behavior therapy
Comparison Sertaline vs
CHT
Subject Information
Depression; Pain
and Consent Form F1JUS-HMCB Duloxetine
Once-Daily Dosing
Versus Placebo in
Patients with Major
Depression and Pain
18+
RCT
Safety/Efficacy
Study
Duloxetine
Hydrochloride
na
Treatment of
Bipolar Disorder;
Depression in Youth
Depression
with Bipolar Disorders
8-18
RCT
Phase III
Fluoxetine
Na
Smoking; Depression
Anx_6.15-8
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Condition
Study Design
Intervention
Mechanism
Treatment of
Depression in
Parkinson's Disease
Trial
Parkinson Disease;
Depression
35-80
RCT
Safety/Efficacy
Study
Phase II
Drug: nortriptyline
Drug: paroxetine
Magnetic Stimulation
for Parkinson Disease
Parkinson's Disease;
Depression
40-75
RCT
Procedure: Prefrontal
transcranial magnetic
brain stimulation &
ECT
Neurostimulation
improve mood and
psychomotor
Clinical Trial of
Fluoxetine in Anxiety
and Depression in
Children, and
Associated Brain
Changes
Depression; Mood
Disorder; Anxiety
Disorder; Healthy
9-17
Observational
Fluoxetine
Improve attention and
emotional memory
Treatment of
Depression with
Massage in HIV
Acquired
16+
Immunodeficiency
RCT Efficacy
Syndrome; HIV
Phase II
Infections; Depression
Procedure: Massage
Therapy
Plasma cortisol increases?
Treatment Effects on
Platelet Calcium in
Hypertensive and
Depressed Patients
Depression;
Hypertension
25-65
RCT Pharmacodynamic
s
Drug: paroxetine
Behavior: ongoing
psychological
screening
Platelets of hypertensive
patients with depressive
symptomatology are
hyper-responsive to
serotonin
Combination
Chemotherapy Plus
Fluoxetine in Treating
Patients With
Advanced or
Recurrent Non-Small
Cell Lung Cancer
Anxiety Disorder;
Depression; Fatigue;
Non-small cell lung
cancer
Any with SCC
RCT
Drug: cisplatin
Improving treatment
Drug: fluoxetine
protocol
Drug: gemcitabine
Procedure: chemother
apy
Procedure: psychosoci
al assessment/care
Procedure: supportive
care/therapy
Methylphenidate to
Improve Quality of
Life in Patients
Undergoing Radiation
Therapy for Brain
Tumors
adult brain tumor;
brain metastases;
cognitive and
functional effects;
Depression; Fatigue;
Quality of Life
18+
RCT
Drug: methylphenidate Improving QoL
Complications of
therapy assess/mgt
Fatigue assess/mgt
Psychosocial
assess/mgt
Quality-of-life
assessment
Radiation therapy
Supportive
care/therapy
PUFA Augmentation
in Treatment of Major
Depression
Major depression
18-65
RCT Efficacy
Phase III
Drug: Polyunsaturated PUFA enhance
Fatty Acids (PUFA)
Antidepressant therapy
Drug: Citalopram
Treatment of Major
Depression with St.
John's Wort
(Hypericum)
Major Depression
18+
Drug: Sertraline
RCT efficacy and
Drug: Hypericum
safety
perforatum (St. John's
Comparative
wort)
study of a natural
Anx_6.15-9
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Condition
Study Design
Intervention
Mechanism
medicine
Treatment Resistant
Depression Study
Depression; Major
Depressive Disorder
18-85
RCT Phase III
2002-open
risperidone
Medication Treatment Depression; Major
for Psychotic
Depressive Disorder
Depression
18+
RCT Safety &
Efficacy
2003-2007
Drug: Olanzapine
Drug: Sertraline
Drug: Lithium
Raloxifene and
Rimostil for
PerimenopauseRelated Depression
Any
RCT Phase IV
2002-?
Drug: Evista, Rimostil, Selective estrogen
Alora
receptor modulators
(SERMS)
Transcranial magnetic Depression
stimulation in
depression
18+
RCT Phase II
1999-2001
Device: repetitive
transcranial magnetic
stimulation
Multiphase Efficacy
Study of venlafaxine
ER to Treat Recurrent
Depression
18+
RCT
Phase IV
2002-?
Drug: Venlafaxine ER
Drug Therapy to Treat Depression
Minor Depression
18-85
RCT
2003-?
Drug: Citalopram
Drug: St. John's Wort
Preventing the
Recurrence of
Depression with
Drugs and
Psychotherapy
Depression
18+
RCT Efficacy
Phase IV
2002-?
Behavior: Cognitive
Therapy
Drug: Antidepressant
medications
Duloxetine vs. active
comparator for the
treatment of
depression
Depression
18+
RCT Efficacy
Phase IV
Drug: Duloxetine
Hydrochloride
Drug: Other
Electroconvulsive
Depression
Therapy (ECT) Versus
Drug Therapy for the
Treatment of
Depression
18-85
RCT Efficacy &
Safety
Drug: Lithium
Drug: Nortriptyline
Procedure: Continuati
on Electroconvulsive
Therapy
Comparison of Three
Electroconvulsive
Therapy (ECT)
Techniques for the
Treatment of Major
Depression
Depression
18+
RCT
2002-?
Procedure: Electroconv Improving technique
ulsive Therapy (three
application
procedures)
Duloxetine vs. active
comparator in the
treatment of patients
Depression
18+
RCT
Phase IV
Drug: Duloxetine
Hydrochloride
Climacteric
Depression
Depression
Anx_6.15-10
First trial MD with
delusions funded by
NIMH
CT to avoid recurrence
For avoiding relapse after
ECT
Compares Drugs vs CECT
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Condition
with depression
Study Design
Intervention
Mechanism
2004?
An Investigational
Drug Compared to a
Marketed Drug and
Placebo in the
Treatment of Patients
with Depression
Depression
18+
RCT
Phase III
2004?
Drug: Investigational
antidepressant drug
Participant Features
Affecting Depression
Treatment
Depression
18-66
RCT Efficacy
2003-2007
Drug: Escitalopram
Comparative
Behavior: Interpersona
l Psychotherapy
65+
RCT
Safety/Efficacy
Study
Phase IV
2003-2008
Drug: Antidepressants
Medication Treatment Depression
for Depression in
Nursing Home
Residents
Acupuncture in the
Treatment of
Depression
Depressive Disorders; 18-60
Depression
RCT
Phase III
1997-2002
Procedure: Acupunctur
e
Magnetic Stimulation
Therapy for Treating
Vascular Depression
Depressive Disorder;
Depression
51-89
RCT
Efficacy/Safety
Phase III
2001-?
Procedure: Repetitive
Transcranial Magnetic
Stimulation
Drug: Citalopram
Treatment of Vascular Depressive Disorder;
Depression
Depression
60+
RCT efficacy and
Pharmacocinetic
Drug: Sertraline
(Zoloft)
Procedure: MRI Scan
Procedure: Cognitive
Testing
Procedure: EKG
Ethnic Variations in
Antidepressant
Response
Depression;
Depressive Disorder
18-70
RCT Efficacy
Phase IV
2002
Drug: Citalopram
Research Evaluating
the Value of
Augmenting
Medication with
Psychotherapy
(REVAMP)
Depression;
Depressive Disorder
18-75
RCT Efficacy
2003-2006
Behavior: Supportive
Therapy
Behavior: Cognitive
Behavioral Analysis
System of
Psychotherapy
Drug: Sertraline
Drug: Escitalopram
Drug: Bupropion SR
or XL
Drug: Venlafaxine XR
Drug: Mirtazapine
Improving Hispanic
Retention in
Antidepressant
Therapy
Depression;
Depressive Disorder
Hispanics 18-65
Drug: Sertraline
Non-Ramdomized Drug: Venlafaxine
2002-2004
Extended Release
Anx_6.15-11
ST in drug failure cases
Treatment retention
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Condition
Study Design
Intervention
Electroacupuncture for Depression;
Major Depression
Depressive Disorder
18-80
RCT Phase II
Procedure: electroacup
uncture
Sertraline and
Cognitive Therapy in
Depressed Alcoholics
Alcoholism;
Depression
18-65
RCT Efficacy
Phase II
?-2002
Drug: sertraline
(Zoloft)
Behavior: cognitive
behavior therapy
Sertraline for Alcohol
Dependence and
Depression
Alcoholism;
Depression
21-65
RCT Phase IV
?-2004
Drug: naltrexone
(Revia)
Drug: sertraline
(Zoloft)
Drug Treatment for
Alcoholism;
Depressed Alcoholics Depression
(naltrexone/fluoxetine)
18-65
RCT Phase IV
?-2005
Drug: naltrexone
(Revia)
Drug: fluoxetine
(Prozac)
Treating Alcohol Use
In Older Adults With
Depression
55+
RCT Phase IV
1999-2002
Drug: NALTREXONE
Relapse Prevention for Bipolar Disorder;
Bipolar Type-II
Depression
Disorder
18+
RCT Phase IV
Drug: Fluoxetine
Drug: Lithium
Antidepressant
Heart Failure,
Medication Treatment Congestive;
for Depression in
Depression
Individuals with
Congestive Heart
Failure
45+
RCT Efficacy
Phase III
?
Drug: Sertraline
The Depression in
Alzheimer's Disease
Study (DIADS)
Any
RCT Phase IV
?
Drug: Sertraline
[Zoloft]
Preventing Post-Stroke Depression;
Depression
Cerebrovascular
Accident
31-89
RCT Phase III
2002-?
Drug: Nortriptyline
Behavior: Problem
Solving Therapy
Drug: Escitalopram
Optimizing
Electroconvulsive
Therapy for
Depression
18+
RCT Phase IV
2001-2006
Procedure: Electrocon
vulsive therapy
Drug: Nortriptyline
Drug: Venlafaxine
Drug: Lithium
SAM-e for the
Parkinson's Disease;
Treatment of
Depression
Depression in Patients
with Parkinson's
Disease
30-80
RCT
2003-2006
Drug: s-adenosylmethionine
Drug: escitalopram
Sertraline Compared
With Hypericum
18+
RCT
Drug: Hypericum
perforatum
Alcoholism;
Depression
Alzheimer Disease;
Depression
Depression;
Depressive Disorder;
Bipolar Disorder
Depression;
unspecified adult
Anx_6.15-12
Mechanism
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Condition
Perforatum (St. John's solid tumor, protocol
Wort) in Treating Mild specific
to Moderate
Depression in Patients
With Cancer
DextroamphetamineAmphetamine
Compared With
Methylphenidate in
Treating Children
With Depression and
Problems With
Memory, Attention,
and Thinking Caused
By Cancer Treatment
Study Design
?
Intervention
Mechanism
Drug: sertraline
Procedure: biologically
based therapies
Procedure: cancer
prevention
intervention
Procedure: compleme
ntary and alternative
therapy
Procedure: herbal
medicine / botanical
therapy
Procedure: nutritional
supplementation
Procedure: psychosoci
al assessment/care
Procedure: supportive
care/therapy
unspecified childhood 6-17
solid tumor, protocol RCT Phase II
specific; Depression;
neurotoxicity
Drug: dextroampheta
mine-amphetamine
Drug: methylphenidat
e
Procedure: chemoprot
ection
Procedure: complicatio
ns of therapy
assessment/manageme
nt
Procedure: neurotoxici
ty attenuation
Procedure: supportive
care/therapy
Evaluation of
Bipolar Disorder;
Repetitive
Mood Disorder;
Transcranial Magnetic Unipolar Depression
Stimulation (rTMS) in
the Treatment of Mood
Disorders
18-90
Interventional
Study
Phase II
1996-?
Device: Magstim
Super Rapid Magnetic
Stimulator
Device: Cadwell MES10
Omega-3 Fatty Acids
in the Treatment of
Bipolar Disorder: A
Double-Blind, PlaceboControlled Trial
Bipolar Disorder;
Involutional
Depression; Mood
Disorder
Any
RCT Phase II
1999-2002
Drug: Ethyl
omega-3 fatty acids in the
Eicosapentaenoic Acid form of eicosapentaenoic
Drug: OmegaBrite
ethyl esters (EPA) =
Mood stabilizer
Safety and Efficacy
Trial of the Use of
Quetiapine Fumarate
(SEROQUEL ) in the
Treatment of Patients
with Bipolar
Depression
Bipolar Disorder;
Depression, Bipolar
18-65
RCT Phase III
?
Drug: SEROQUEL
(quetiapine fumarate)
Tablets
Treatment of
Adolescent Suicide
Major Depressive
Disorder; Depressive
12-18
RCT Phase III
Drug: fluoxetine
Drug: sertraline
Anx_6.15-13
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Attempters (TASA)
Condition
Disorder not
otherwise specified
(NOS); Dysthymic
Disorder
Study Design
Intervention
2004
Drug: citalopram
Drug: escitalopram
Drug: buproprion
Drug: mirtazapine
Drug: venlafaxine
Drug: lithium
Behavior: Cognitive
Behavioral Therapy
Adult Outpatients
Major Depressive
with Major Depressive Disorder
Disorder
18-75
RCT Phase III
?
Drug: DVS-233 SR
Efficacy And Safety Of Major Depressive
Three Fixed Doses Of Disorder
DVS-233 SR In Adult
Outpatients With
Major Depressive
Disorder
18-75
Phase III
?
Drug: DVS-233 SR
Mechanism
Study of Duloxetine in Depression, Cognition 65+
Elderly Patients with
RCT Phase III
Major Depressive
Disorder
Drug: Duloxetine
Comparing
Drug: "Investigational
Drug"
Acute Treatment of
Bipolar II Depression
Bipolar Depression
18-55
RCT Phase III
2003
Drug: Lithium
Drug: Lamotrigine
The Treatment of
Children and
Adolescents with
Treatment-Resistant
Depression
Bipolar Disorder
Observational
2002-2004
Paroxetine (Paxil),
sertraline (Zoloft) or
fluoxetine (Prozac
Clinical Trial of
Felbamate for
Treatment-Resistant
Bipolar Depression
Bipolar Disorder
18+
RCT
Efficacy/Safety
2002-2004
Felbamate
Evaluation of
Clonazepam and
Paroxetine for Panic
Disorder with
Depression
Panic Disorder
18+
RCT Phase IV
2002
clonazepam
SSRI
18-60
Observational
2004
Alpha-methylparatyrosine (AMPT)
fMRI
Neural Correlates of
Neurophysiology
Depressive Symptoms
and Reward Related
Mechanisms
Following AMPT
Depletion in Remitted
Depressed Patients Off
Treatment and
Healthy Controls
Anx_6.15-14
reduces glutamatergic
throughput via inhibition
of glutamate release and
NMDA, AMPA, and
metabotropic glutamate
receptor blockade
Catecholamine depletion
(CD)
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Condition
Study Design
Intervention
Mechanism
The Effects of
Dutasteride on Mood,
HPA Axis, and Serum
Allopregnanolone
Levels in Women with
Menstrual-Related
Mood Disorders and
Controls
30-45
RCT
Phase II
2004
Drug: Dutasteride
Clinical Trial of
Bipolar Disorder
Pramipexole in Bipolar
Depression
18-60
RCT
Safety/Efficacy
Phase II
2001-?
Pramipexole +
lithium or divalproex
An Investigation of the Depressive Disorder
Antidepressant
Efficacy of the 5-HT2A
Antagonist, M100907,
in Combination with
Citalopram in
Treatment Resistant
Depression
18-65
RCT
Safety/Efficacy
Phase II
2003-?
Drug: MDL100.907
5-hydroxytryptamine 2A
(5-HT2A) antagonist
Yohimbe to Induce
Rapid Antidepressant
Effects
18-60
RCT
Safety/Efficacy
Phase II
2004-?
Yohimbe
activate the
noradrenergic system
during REM sleep
Treatment of Mid-Life- Depressive Disorder;
Related Mood
Mood Disorder
Disorders
40-65
RCT
Safety/efficacy
1995-2004
Drug: Dehydroepiandr DHEA levels associated
osterone
to depression
Continuation
Major Depressive
Electroconvulsive
Disorder
Therapy vs Medication
to Prevent Relapses in
Patients with Major
Depressive Disorder
18-80
RCT
Safety/efficacy
Comparative
Phase IV
1997-?
Drug: Nortriptylinelithium (NOR-Li)
Procedure: Bilateral
electroconvulsive
therapy (ECT)
Drug: Continuation
therapy
Behavior: Continuatio
n ECT
Treatment of Patients Major Depressive
with Major Depressive Disorder
Disorder with an
Investigational
Compound
18+
RCT
Safety/efficacy
Experimental
Compound
Open-Label Treatment Major Depressive
with Duloxetine
Disorder
Hydrochloride OnceDaily Dosing for
Evaluation of
Stabilization Dose in
Patients with Major
18+
Non-Ramd Phase
III
2002
Drug: duloxetine
Anx_6.15-15
5 alpha-reductase
inhibitor blocks
progesterone metabolism
(allopregnanolone)
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Condition
Study Design
Intervention
Mechanism
Depression
A 6 Week Study to
Determine the
Effectiveness of
R228060 in Adult
Subjects with Major
Depressive Disorder
Major Depressive
Disorder
18-65
RCT Phase II
?-2004
Drug: R228060
Drug: Placebo and
Paroxetine
Efficacy And Safety Of Major Depressive
Two Fixed Doses Of
Disorder
DVS-233 SR In Adult
Outpatients With
Major Depressive
Disorder
18-75
RCT Phase III
?
Drug: DVS-233 SR
DVS-233 SR For
Major Depressive
Prevention Of
Disorder
Depressive Relapse In
Adult Outpatients
With Major Depressive
Disorder
18-75
RCT Phase III
?
Drug: DVS-233 SR
Combination Therapy Bipolar Disorder
for the Treatment of
Bipolar Disorders
16+
RCT Phase III
2002-2005
Drug: Lithium
Drug: Lamotrigine
Drug: Divalproex
Clinical Trial of
Depressive Disorder;
Leuprolide Acetate for Mood Disorder
the Treatment of PMS
18-40
RCT
safety/efficacy
1990
Drug: Luprolide
Acetate 3.75 mg
New Drugs in the
Treatment of Mood
Disorders
18-75
RCT Phase II
1995-2001
Lamotrigine (Lamictal) Anticonvulsivants
and Gabapentin
(Neurontin)
Anxiety Disorder;
Mood Disorder;
Psychotic Disorder
Acute Effectiveness of Bipolar Disorder;
Additional Drugs to
Depressive Disorder
the Standard
Treatment of
Depression
18+
Buproprion
RCT Comparative (Wellbutrin).
1995-2002
Sertraline (Zoloft).
Venlafaxine (Effexor)
High Intensity Light
Therapy in
Alzheimer's Disease
Alzheimer's Disease;
Dementia
60+
RCT
2003-2004
Device: high-intensity
light therapy
Combined Hormone
Replacement in
Menstrually-Related
Mood Disorders
Premenstrual
Syndrome
18-50
2000-?
estradiol or
progesterone
leuprolide acetate
Clinical Trial of
Propranolol for
Seasonal Affective
Seasonal Affective
Disorder; Healthy
18-50
RCT
Safety/Efficacy
Propanolol
Anx_6.15-16
Inhibitation of
Melatonine which
regulate light circadian
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Condition
Disorder
Clinical trials of three
non-drug treatments
for winter depression
(SAD).
Study Design
Intervention
2001-?
Mechanism
cycles
Seasonal Affective
18-70
Disorder; Mood
RCT
Disorders; Depressive 1998-2003
Disorders
Device: bright light
box
Device: dawn
simulator
Device: negative ion
generator
Hypercholesterolemia; Females 30-45
Hypertension;
RCT
Depression; Diabetes 2000-?
Mellitus, Type 2
Behavior: Health at
Every Size (HAES)
Behavior: Diet
(Traditional, moderate
energy restriction)
PSYCOLOGICAL
CLINICAL
RESEARCH
Evaluating "Health at
Every Size"(HAES) as
an Alternative Obesity
Treatment Model
Therapy for Depressed Depression; Cognition 60+
Elders with Thought
Disorders
RCT Efficacy
Problems
PhaseIII
2002-2007
Behavior: Problem
Solving Therapy
Behavior: Brief
Supportive Therapy
Depressed elderly with
executive dysfunction
respond poorly to
antidepressants
Cognitive and Drug
Therapy for DrugResistant Depression
21-60yo
RCT
Integrating
Protocol
Compliance
Behavior: Cognitive
therapy
Drug: Desipramine
Optimizing Clinical
Protocol
8-16
Open label
Behavior: psychothera
py
Adjusted Contextual
Psychotherapy
na
Depression; Anxiety
Disorders; Personality
Disorders; Drugresistant depression
Depression In Juvenile Depression; Diabetes
Diabetics
Mellitus, InsulinDependent
Treatment of
Stress Disorders, Post- 21+
Depression in Patients Traumatic; Depression RCT
with PTSD
Self-management
therapy;
Psychoeducational
group therapy
Efficacy of
Telepsychiatry in the
Treatment of
Depression
Depression
Telepsychiatry
Psychological
Treatments for
Scleroderma
Pain; Depression;
18-85
Scleroderma; Systemic
Sclerosis
Standard Follow-up
Compared With
Extended Follow-up in
Treating Patients Who
Have Undergone Stem
Cell Transplantation
for Cancer
Any
RCT
18+
RCT
Anx_6.15-17
Behavior: Cognitivebehavioral therapy
Behavior: Disease/heal
th education
Procedure: complicatio Improving QoL
ns of therapy
assessment/manageme
nt
Procedure: fatigue
assessment/manageme
nt
Procedure: psychosoci
al assessment/care
Procedure: supportive
care/therapy
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Music Therapy to Ease
Pain and Emotional
Distress in Patients
With Hematologic
Cancer Who Are
Undergoing HighDose Therapy and
Stem Cell
Transplantation
...
Condition
Study Design
adult Hodgkin's
18+
lymphoma; adult non- RCT
Hodgkin's lymphoma;
Anxiety Disorder;
childhood acute
myeloid leukemia and
other myeloid
malignancies;
Intervention
Mechanism
Procedure: pain
Decreasing Pain
therapy
Procedure: psychosoci
al assessment/care
Procedure: supportive
care/therapy
Treatment of
Depression; Major
Depression in Nursing Depressive Disorder
Homes
60+
RCT Efficacy
2002-2005
Behavior: Pleasant
Events-Based
Behavioral
Intervention
Therapy for
Depression with Cooccurring Panic or
Anxiety Symptoms
Depression; Mood
Disorder; Anxiety
Disorder; Panic
Disorder; Major
Depressive Disorder
18-60
RCT Efficacy
Phase II
2002-2004
Behavior: Interpersona
l Psychotherapy (IPT)
Behavior: IPT for
Depression with Cooccurring Panic and
Anxiety Symptoms
(IPT-PS)
Treatment of
Depressed Women
Who Have Been
Sexually Abused
Depression
18-65
RCT
2001-?
Behavior: Schema
Therapy
Treatments for
Depression: Drug vs.
Psychotherapy
Depression
18-70
RCT
2001-2006
Behavior: Supportive
Expressive Therapy
Drug: Sertraline
Drug: Pill Placebo
Drug: Venlafaxine
Treatment for
Depression in the
Primary Care Setting
Depression
18+
RCT Efficacy
Phase IV
Behavior: ProblemSolving Treatment for
Primary Care
Treatment for
Depressed
Preadolescent Girls
Depression
Female 9-13
RCT Efficacy
2002
Behavior: Cognitive
Behavioral Therapy
Behavior: Parent
Training
Prevention of
Depression in At-Risk
Adolescents
Depression
13-17
RCT
2003-2008
Behavior: Cognitive
Behavioral Program
Reducing Symptoms
Depression
of Depression in LowIncome Mothers
15+
RCT
Safety/Efficacy
2003-2008
Procedure: Modified
Interpersonal Therapy
Adding Exercise to
Depression
Antidepressant
Medication Treatment
for Depression
18-65
RCT
2003
Behavior: Exercise
As coadyudant for SSRI
Preventing Depression Depression; Macular
65+
Behavior: Problem
Vs Usual care
Anx_6.15-18
Optimization
CBT vs CBT plus Parent
Training
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Condition
in Patients with
Degeneration
Macular Degeneration
Study Design
RCT
2001-2005
Reducing Depression Dementia; Depression 50+
in Caregivers to
RCT Phase II
People with Dementia
2002-2004
Effects of Therapist
Behavior on the
Treatment of
Depressed
Adolescents
Depression;
Depressive Disorder;
Dysthymic Disorder
Intervention
Solving Treatment
Behavior: Behavioral
Skills Training
13-18
Behavior: Cognitive
Non-ramdomized Behavioral Therapy
2003-2005
Cognitive Behavioral Seasonal Affective
Therapy for the
Disorder; Depression
Treatment of Seasonal
Affective Disorder
(SAD)
18+
RCT
2002-2004
Behavior: Light
Therapy
Behavior: Cognitive
Behavioral Therapy
Behavior: Light
Therapy plus
Cognitive Behavioral
Therapy
Middle School to High Depression;
School Transition
Depressive Disorder;
Project
Substance-Related
Disorders
12-15
RCT
2003-2007
Behavior: Coping and
Support Training for
Transition program
Enhancing Recovery in
Coronary Heart
Disease (ENRICHD)
Patients
Cardiovascular
18-75
Diseases; Coronary
RCT? Phase III
Disease; Depression;
1995-2004
Heart Diseases;
Myocardial Infarction;
Myocardial Ischemia
Behavior: social
support
Stress Management
Training in Patients
Undergoing Radiation
Therapy for Cancer
Quality of Life;
Anxiety Disorder;
Depression;
unspecified adult
solid tumor, protocol
specific
18+
?
Procedure: psychosoci
al assessment/care
Procedure: quality-oflife assessment
Procedure: supportive
care/therapy
CVD Risk and Health
in Postmenopausal
Phytoestrogen Users
Bone Diseases;
Cardiovascular
Diseases; Coronary
Disease; Depression;
Heart Diseases;
Myocardial Ischemia;
Osteoporosis;
Postmenopause
45-74 Female
RCT
Phase III
1997-2004
Behavior: dietary
supplements
Drug: genistein
Behavior: diet, soy
proteins
Survival TRaining for
ENhancing Total
Health (STRENGTH):
Distance MedicineBased Exercise and
Diet in Preventing
Body Composition
Change in Patients
Receiving
weight changes;
Quality of Life;
Depression; stage I
breast cancer; stage II
breast cancer; stage
IIIA breast cancer
18+
Interventional
Phase II
?
Procedure: complicatio
ns of therapy
assessment/manageme
nt
Procedure: quality-oflife assessment
Procedure: supportive
care/therapy
Anx_6.15-19
Mechanism
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Condition
Study Design
Intervention
Mechanism
Chemotherapy for
Stage I, Stage II, or
Stage IIIA Breast
Cancer
Study of Health
Promotion in Patients
With Early-Stage
Breast or Prostate
Cancer
stage I breast cancer; 65+
stage II breast cancer; RCT
stage I prostate cancer; ?
stage II prostate
cancer; Fatigue;
Nutrition;
psychosocial
effects/treatment; ...
Procedure: fatigue
assessment/manageme
nt
Procedure: nutritional
support
Procedure: physiother
apy
Procedure: psychosoci
al assessment/care
Procedure: quality-oflife assessment
Procedure: supportive
care/therapy
Clinician Managed
Interpersonal
Psychotherapy
Depression,
Postpartum
18+ Female
RCT
?
Behavior: Interpersona
l Psychotherapy (IPT)
Behavior: Clinician
Managed Interpersonal
Psychotherapy (CMIPT)
Group Therapy for
Postpartum
Depression
Depression,
Postpartum
18+ Female
RCT Efficacy
2002-?
Behavior: MotherInfant Psychotherapy
Behavior: Interpersona
l Psychotherapy
Prevention of
Postpartum
Depression in LowIncome Women
Depression,
Postpartum
18-45 Females
RCT
2001-?
Behavior: Survival
Skills for Moms with
New Babies
Pharmacologic
Treatment of PTSD in
Sexually Abused
Children
Posttraumatic Stress
Disorder; Major
Depressive Disorder;
Anxiety Disorders
10-18
RCT Phase III
2001-2006
Drug: Trauma-focused
Cognitive Behavioral
Therapy plus Sertraline
Drug: Trauma-focused
Cognitive Behavioral
Therapy plus Placebo
Treatment of Post
Traumatic Stress
Disorder in Patients
with other Mental
Illnesses
Stress Disorders, Post- 18-65
Traumatic
RCT Efficacy
Study
2002-2004
Music Imagery for
Leukemia;
Patients Receiving
Lymphoma, NonChemotherapy for
Hodgkin
Leukemia or NonHodgkin's Lymphoma
Behavior: Cognitive
Behavior Treatment
18-80
RCT Efficacy
Phase II
2002-?
Behavior: Music
Imagery
18+
SCL-20 depression
HEALTH CARE
RESEARCH
Effectiveness of Team
Depression
Anx_6.15-20
Collaborative Care
Annex to Chapter 6.15: Depression in Young People and the Elderly
Trial
Condition
Treatment of
Depression in Primary
Care
Study Design
Intervention
Mechanism
Phase II
symptomatology
measure, SF-36V, and
Sheehan functional
impairment measure
Model – Improving
Chronic Care
Mental Nurse Clinic
Improving Health Care
An Integrated Model
of Primary Care in
Mental Health
Depression
18+
RCT
Prevention of Suicide
in the Elderly
Depression
60+
RCT-Prevention
Early Dx by using
models
Treatment for PostStroke Depression
Stroke; Depression
Any with Stroke
RCT
Models of care
Screening Evaluation
for Women with
Postpartum
Depression
Postpartum
Depression
Any
Observational
Dx
None
Outreach and
Treatment for
Depression in the
Labor Force
Depression
18+
RCT Efficacy
2003
Behavior: Care
manager outreach and
monitoring
65+
RCT
1996-2001
System: Casefinding
and Referral System
A Case Finding and
Depression; Urinary
Referral System for
Incontinence;
Older Veterans within Geriatrics
Primary Care
Anx_6.15-21