What Every Psychologist Should Know About the Food and Drug










Antidepressant Use in Children, Adolescents, and Adults

“The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months)”. –FDA


Drug treatment produces clinically significant improvement in 65-75% of people.

40-50% reach full recovery.

Suggests that neurotransmitter levels

(especially monoamines) are low in depressed patients.

Monoamines: serotonin, dopamine, epinephrine, norepinephrine

Opposite may be true in manic patients.

Selective Serotonin Reuptake Inhibitor (SSRI)

Serotonin is released into the synaptic cleft, binds to receptors on the postsynaptic membrane and is then swept away by the reuptake system.

SSRI’s block this reuptake system, allowing the serotonin to remain in the cleft longer and re-bind to receptors.

Although we can guess that SSRI’s work by manipulating serotonin levels, we are still unsure how SSRI’s and other antidepressants relieve depression symptoms.

Antidepressants effect the neurotransmitter systems within a few hours, but people must take the drug for several weeks before experiencing elevated mood.

Data from the FDA antidepressant trials

Differences in suicidality rates were statistically significant between the drug and placebo groups for those 18 and under, but the relative magnitude was small.

There were no suicides across the 4,400 individuals in this group.

Statistically significant, but is this clinically significant?

Keep in mind the overall success rate of antidepressants.

An important distinction should be made between suicidal thinking and death by suicide.

Research has revealed a trend towards increased suicidal thinking, but not death, in those under age 18.

According to the FDA, the purpose of the

Black Box Warning is to inform health care practitioners, patients, and families to monitor for these increased thoughts within the first few months of treatment.

There is a general trend for increased suicide with age.

In 2005, the elderly represented 12.4% of the population, but accounted for 16.6% of suicides.

Young people made up 16.6% of the population, and accounted for 12.9% of suicides.

The National Comorbidity Survey found no significant differences in suicide risk between young people and older adults.

Why do we assume that teen suicide is more prevalent than it actually is?

Media coverage?



Social networking sites?


Teen suicide in clusters?

Peers more important than parents?

More sensitive to what others are doing?

Health professionals may be hesitant to prescribe antidepressant medications.

No increase in other treatment options.

More referrals to specialists/psychiatrists.

Is this good or bad?

Rudd et al. argue that this is bad.

Anywhere from 30%-75% of patients no-show for appt.

Following the appearance of the warning label, SSRI prescriptions have fallen short of expectations.

Especially for adolescents.

In addition, one Canadian study found that child and adolescent suicide rates have tripled since the warning.

Another study found that 91% of practitioners misunderstood the warning to mean increased risk of death.



Recent literature demonstrates a reduction in suicide risk with SSRI use.

Low rates of SSRI antidepressants reported in toxicology results of suicide cases.

Only 1 in 5 adults were taking antidepressants at the time of suicide.

Data show clinical improvement and lower risk for suicide following treatment with SSRI medications.

No increased risk for suicide after treatment with SSRIs following a major depressive episode.

“Treatment efficacy needs to be factored in when considering risk,” (Rudd, et al.)

Antidepressants provide relief in 65-75% of cases

Should the Black Box Warning stay?

As clinical psychologists, what are some ways we can help solve this problem?

Inform clients and parents about a possible increase in suicidal thoughts.

Help them to understand what the black box warning really means, and the research behind the antidepressant trials.

Recommend therapy along with drug treatment.

Imagine you receive the following case while working at the

PSC, what are your recommendations?

What are your concerns?



Michael is a 15 year old male. His mother recently contacted the PSC with concerns about Michael’s low mood and isolation from his peers. Upon interview, Michael stated that he has been feeling very sad for about 3 months, and sometimes wonders what it would be like if he were no longer alive.

Psychotherapy can be an alternative treatment for depression in children.

As psychologists, we will often have contact with clients taking antidepressant medications.

We will play a role in medication monitoring and serve as a

“scientific resource.”

We may also play a role in helping clients make treatment decisions.

The Black Box Warning on Antidepressants has led to misunderstanding of their true risks.

Statistically, there are more suicidal thoughts in children and adolescents taking antidepressants (but not actual suicides.)

The Black Box Warning has changed clinical practice, and many depressed young people may not be getting the help they need.

As clinical psychologist, it is our job to convey the real meaning of the Black Box

Warning: that children and adolescents should be monitored for increased suicidal thoughts.

We should help clients and parents understand the true risk associated with antidepressants, as well as the potential benefits.

Not treating depression may be the most dangerous course of all.