Antidepressant Safety in Kids Study
Condition: Anxiety Disorders; Depressive Disorders; Eating Disorders; Obsessive Compulsive Disorder
MeSH terms: Anxiety Disorders; Depressive Disorder; Depression; Feeding and Eating Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Observational

Summary: 
      This study will evaluate the risks and benefits of treatment with a selective serotonin
      reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor in children and adolescents
      with a pre-specified anxiety disorder, depressive disorder, eating disorder, or
      obsessive-compulsive disorder.
    

Detailed description: 
      The Antidepressant Safety in Kids (ASK) study is part of the Child and Adolescent Psychiatry
      Trials Network (CAPTN).

      Selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor
      (SNRI) medications are prescribed to approximately 2 to 3% of American children. Evidence
      suggests that these medications are beneficial for treating obsessive-compulsive disorder
      (OCD), anxiety disorders, and major depressive disorder. Following hearings in February and
      September of 2004, the FDA mandated Black Box warnings for all antidepressants, cautioning
      prescribers about the risk of treatment-emergent suicidal tendency in children and
      adolescents treated with these drugs. Although prescribing waned somewhat following the
      warning, many children continue to receive SSRIs and SNRIs for a variety of conditions that
      do not have empirically validated alternative treatments. Therefore, there is a pressing need
      to clearly understand the safety, tolerability, and effectiveness of SSRIs and SNRIs in
      children and adolescents.

      Specific Aim:

      The purpose of this study is to evaluate the safety, tolerability, and effectiveness of SSRI
      and SNRI medications for children and adolescents with anxiety disorders, depressive
      disorders, eating disorders, or obsessive-compulsive disorder. The study will characterize
      predictors of outcome, including demographic, disease severity, comorbidity, concomitant
      treatment, and genetic variation. This information will help clinicians to better understand
      the balance of risk and benefit associated with antidepressants and to answer the question of
      which treatment is best for which child.

      Three specific aims include the following:

        1. To evaluate the within-subject benefit of antidepressant treatment over acute (12 weeks)
           and maintenance (an additional 6 months) of treatment;

        2. To evaluate the adverse event profile for harm to self, harm to others, and psychiatric
           and nonpsychiatric adverse events;

        3. To evaluate potential moderators and mediators of benefits and adverse events.

      Design:

      This will be a prospective longitudinal cohort study of 2,420 consecutively enrolled patients
      who are prescribed an SSRI or SNRI (Citalopram [Celexa], Escitalopram [Lexapro], Fluoxetine
      [Prozac/Prozac Weekly], Fluvoxamine [Luvox], Paroxetine, [Paxil/Paxil-Cr], Sertraline
      [Zoloft], Venlafaxine [Effexor/Effexor XR], Duloxetine [Cymbalta]). Patients will be drawn
      from the practices of approximately 200 CAPTN participants in the United States and Canada.

      Study Timeline:

      This study will have two phases: 1) an acute treatment phase following initiation of
      treatment with any SSRI or SNRI of the clinician's choosing and 2) a long-term follow-up
      phase. The acute treatment phase will last 12 weeks and the long-term follow-up phase will
      occur 6 and 9 months after initiation of treatment.

      Treatment:

      Flexible upward titration of any of the commercially available SSRI or SNRI medications. As
      decided by the treating doctor, titration will depend on the severity of illness, degree of
      response, and adverse event profile. With few exceptions, concomitant treatments are
      permitted.

      Assessment:

      Study assessment milestones will occur at baseline, Week 12, and Months 6 and 9 or at study
      entry. CAPTN uses a "no query rule" electronic data capture system. The parent and child will
      complete a pen and paper workbook consisting primarily of the DISC Predictive Scales (DPS-IV)
      and the Pediatric Adverse Event Rating Scale (PAERS). Based on this information and on
      clinical interview, the treating clinician will complete the fully web-based EDC modules at
      baseline and at all treatment and end-of-study visits.
    

Intervention name(s): Selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) medications
Intervention type(s): Drug
Intervention description(s): Treatment with SSRIs or SNRIs
Intervention MeSH terms: Norepinephrine; Serotonin; Selective Serotonin Reuptake Inhibitors
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents age 7 to 17 years old.
      
Keywords: Anxiety; Major Depression; Anorexia; Bulimia; OCD; Antidepressant; SSRI; SNRI