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Characteristics of Pediatric Antidepressant Trials

Characteristics of Pediatric Antidepressant Trials. Gregory M. Dubitsky, MD Division of Neuropharmacological Drug Products FDA. Objective. Descriptive only. Will not address effect of study characteristics on suicidality risk: See Dr. Hammad’s Presentation. Study Pool.

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Characteristics of Pediatric Antidepressant Trials

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  1. Characteristics of PediatricAntidepressant Trials Gregory M. Dubitsky, MD Division of Neuropharmacological Drug Products FDA

  2. Objective Descriptive only. Will not address effect of study characteristics on suicidality risk: See Dr. Hammad’s Presentation

  3. Study Pool • 23 placebo-controlled studies conducted between 1984 and 2001. • 9 drugs. • 5 indications (major depression, OCD, GAD, SAD, ADD).

  4. Common Design Features • Randomized. • Double-blind. • Placebo-controlled. • Parallel group. • Flexible-dose.

  5. Basic Study Design See Handout: Table 1 • Drug, study, indication. • Age range. • Number of patients in analysis by TX. • Duration of double-blind TX. • Protocol-specified dose range.

  6. Screening and Key Exclusionary Criteria See Handout: Table 2 • Extensive diagnostic screening. • Placebo lead-in preceding DB TX (and exclusion of placebo responders). • Exclusionary criteria: H/O treatment resistance, current suicide risk, H/O suicide attempt, bipolar disorder, family H/O bipolar disorder.

  7. Other Study Features (see Appendix to my review) • study dates/location/number of centers. • stratified randomization by age group. • exclusionary criteria: -homicidal risk. -psychotic symptoms. -alcohol/drug abuse. -borderline personality disorder. -eating disorder.

  8. Notable Study Differences • Prozac HCCJ (MDD): small & terminated early. • One active-control study: - Paxil 329 (MDD) (imipramine). • Two studies included inpatients: - Celexa 94404 (MDD) & Wellbutrin 75 (ADD). •Three studies used extensive DX screening: -Prozac X065 & HCJE; Paxil 329 (all MDD).

  9. Post-DB Phase TX Options Variable across trials: • Taper of acute TX (8 trials). • Abrupt D/C (7 trials). • Open-label TX (5 trials). • Continued DB TX (3 trials). Also variable within trials: • e.g., Paxil 329 (MDD) - responders continued DB TX, non-responders tapered. Variable follow-up hindered W/D effect analysis.

  10. No study was specifically designed to assess suicidality. • suicide attempts and ideation detected only by routine safety monitoring: -treatment-emergent adverse events. -suicide-related items on depression scales (CDRS-R, K-SADS, HAM-D, and MADRS). • AE description often incomplete or vague.

  11. Conclusions Potential influence of study design characteristics on suicide risk: See Dr. Hammad’s analysis.

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