M. David Rudd Lilianna Cordero Craig J. Bryan Presented by Kristin Sopko

1. What Every Psychologist Should Know About the Food and Drug Administration’s Black Box Warning Label for Antidepressants M. David Rudd Lilianna Cordero Craig J. Bryan Presented by Kristin Sopko

2. Symptoms of Depression • Sleep • Interest • Guilt • Energy • Concentration • Appetite • Psychomotor • Suicide

3. In 2004, The Food and Drug Administration placed a black box warning on all antidepressant drugs used with children and adolescents.In 2007, the label was updated to include people up to 24 years old. 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 (www.fda.gov/cder/drug/antidepressants/default.htm)

4. Treatment with Antidepressants • 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.

5. How do Antidepressants Work? • 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.

6. Some common of SSRIs… • 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.

7. Back to Rudd, Cordero, & Bryan • 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 anti-depressants.

8. Suicidal thinking vs. Death by Suicide • 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.

9. Actual suicide rates show a decreased risk for children and adolescents.

10. Suicide and Age • 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.

11. Teen Suicide • Why do we assume that teen suicide is more prevalent than it actually is? • Media coverage? • http://www.youtube.com/watch?v=tdvL5v8s2ec • Social networking sites? • http://www.sphere.com/2009/11/03/is-teen-suicide-contagious/ • Teen suicide in clusters? • Peers more important than parents? • More sensitive to what others are doing?

13. Unintended Consequences of The Black Box Warning • 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.

14. Unintended Consequences • 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. • http://www.youtube.com/watch?v=mdcWNyzoOrE

15. Considering Treatment Effectiveness When Determining Suicide Risk • 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.

16. Considering Treatment Effectiveness When Determining Suicide Risk • 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?

17. Implications for Psychologists in Clinical Practice • 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.

18. Case Conference… • 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. http://www.youtube.com/watch?v=Kvx_kT8H_5w

19. Implications for Psychologists in Clinical Practice • 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. Psychotherapy can be an alternative treatment for depression in children.

20. Take Home Points • 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.

21. Take Home Points • 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.

22. Thank You!