Zoloft trial on 7 yr olds: National Institute of Mental Health (NIMH) risk vs. benefit?

Zoloft (Sertraline) has a black box warning by the FDA in young adults age 18-24. Antidepressant Use in Children, Adolescents, and Adults.

Antidepressant Use in Children, Adolescents, and Adults

[5/2/2007] 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).

List of Antidepressant Drugs with Medication Guides

Anafranil (clomipramine)
Asendin (amoxapine)
Aventyl (nortriptyline)
Celexa (citalopram hydrobromide)
Cymbalta (duloxetine)
Desyrel (trazodone HCl)
Elavil (amitriptyline)
Effexor (venlafaxine HCl)
Emsam (selegiline)
Etrafon (perphenazine/amitriptyline)
fluvoxamine maleate
Lexapro (escitalopram oxalate)
Limbitrol (chlordiazepoxide/amitriptyline)
Ludiomil (maprotiline)
Marplan (isocarboxazid)
Nardil (phenelzine sulfate)
nefazodone HCl
Norpramin (desipramine HCl) Pamelor (nortriptyline)
Parnate (tranylcypromine sulfate)
Paxil (paroxetine HCl)
Pexeva (paroxetine mesylate)
Prozac (fluoxetine HCl)
Remeron (mirtazapine)
Sarafem (fluoxetine HCl)
Seroquel (quetiapine) <--------this is an antipsychotic-----<<<---antipsychotic
Sinequan (doxepin)
Surmontil (trimipramine)
Symbyax (olanzapine/fluoxetine) <-----combo of Prozac and antipsychotic Zyprexa
Tofranil (imipramine)
Tofranil-PM (imipramine pamoate)
Triavil (perphenazine/amitriptyline)
Vivactil (protriptyline)
Wellbutrin (bupropion HCl)
Zoloft (sertraline HCl)
Zyban (bupropion HCl)

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This study is trialed on youth age 7-19 years old. (that's the average 2nd grade child at age 7)

Brain Markers of Anxiety Disorders and SSRI Treatment in Children and Adolescents

This study is currently recruiting participants.

Verified on March 2010 by National Institute of Mental Health (NIMH)


First Received on July 9, 2010. No Changes Posted
Sponsor: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT01160588


Purpose
This study will attempt to identify gene and brain activity markers that predict whether children and adolescents with anxiety disorders will respond to selective serotonin reuptake inhibitor medications.

Social Phobia
Generalized Anxiety Disorder
Separation Anxiety Disorder

Sertraline treatment: Experimental
Participants with generalized social anxiety disorder will undergo MRI scanning and sertraline treatment.
Intervention: Drug: Sertraline (ZOLOFT)

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Zoloft goes down in the (my)books for being the worst nightmare for my then 13 yr old, who had suicidal thinking and risky behaviors (attempted car jumping while in vehicle on freeway for starters). I wouldn't recommend the drug for kids, teens and the withdrawals were worse. The result of SSRI reaction in my child has been to classify her as med sensitive, and NO SSRI and other drugs that have had same reaction are ever to be given again. This task has been over time to remind doctors that these reactions have been near deadly for my now adult child, over the last few years doctors have entertained the idea of re-trying them, which causes me to go pale sheet white. You never want to see someone you love go wild on SSRI's and try to harm themself and see the behaviors stop with the removal of the drug....because then, you'll have been to the dark side of 'psychiatric help' that I have seen, and it's not pleasant.