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Antidepressants and Suicidality in Adults: Data Overview. M. Lisa Jones MD, MPH Medical Reviewer Division of Psychiatry Products Psychopharmacologic Drugs Advisory Committee December 13, 2006. Antidepressants Studied. FDA Data Request Letters.

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antidepressants and suicidality in adults data overview

Antidepressants and Suicidality in Adults:Data Overview

M. Lisa Jones MD, MPH

Medical Reviewer

Division of Psychiatry Products

Psychopharmacologic Drugs Advisory Committee

December 13, 2006

fda data request letters
FDA Data Request Letters
  • FDA analysis based on randomized, controlled trial datasets provided by the sponsors of the antidepressant drugs:
    • FDA sent four data request letters to sponsors from Dec. 2004 to Aug. 2005
    • Resulting sponsor datasets received by the FDA from Sept. 2005 to Sept. 2006
selecting trials for the dataset
Selecting Trials for the Dataset
  • FDA letter provided the following guidance to sponsors on the studies to include in the dataset:
    • Randomized, placebo-controlled trials only
    • Trials for any indication
    • Trials of any length
    • Trials with at least 20 subjects per treatment arm
  • Sponsors submitted a listing of the trials they intended to include/exclude, and the FDA provided feedback on the trials to be included in the final datasets
study indication groups
Study Indication Groups
  • Major depressive disorder (MDD)
  • Other depressive disorders
  • Other psychiatric disorders
  • Behavioral disorders
  • Other disorders
  • Trials categorized by reviewer consensus
  • MDD and Non-MDD datasets submitted separately

Non-MDD Indications

other depressive disorders
Other Depressive Disorders
  • MDD or Bipolar Disorder
  • Premenstrual Dysphoric Disorder
  • Post Natal Depression
  • Seasonal Affective Disorder
  • Atypical Depression
  • Bipolar Disorder
  • Depression (Unspecified)
  • Depression (Non-MDD)
  • Dysthymia
  • Dysthymia or Major Depression
other psychiatric disorders
Other Psychiatric Disorders
  • ADHD
  • Adjustment Disorder
  • Anxiety Disorders
  • Alzheimer’s Disease
  • Bulimia
  • Generalized Anxiety Disorder
  • Generalized Social Phobia
  • Negative Symptoms Of Schizophrenia
  • Neurasthenia
  • Non-Depressed OCD
  • Obsessive Compulsive Disorder
  • Pain Disorder
  • Panic Disorder
  • Post-traumatic Stress Disorder
  • Social Anxiety Disorder
other behavioral disorders
Other Behavioral Disorders
  • Obesity / Diabetes or Glucose Intolerance
  • Smoking Cessation
  • Weight Loss
  • Weight Maintenance
  • Alcoholism
  • Insomnia
  • Insomnia and Anxiety Preceding Surgery
  • Obesity
  • Obesity and Hypertension
  • Obesity, Hypertension and Diabetes
other disorders
Other Disorders
  • Stress Urinary Incontinence
  • Sexual Dysfunction
  • Sleep in Healthy Volunteers
  • Urge Urinary Incontinence
  • Diabetic Neuropathy
  • Fibromyalgia
  • Mixed Urinary Incontinence
  • Migraine Prophylaxis
  • Neuropathic Pain
  • Non-Ulcer Dyspepsia
  • Premature Ejaculation
event identification
Event Identification
  • To identify potentially suicide-related adverse events (PSRAEs), sponsors were asked to search the trial preferred terms, verbatim terms and comments for suicide-related text strings (e.g. “accident-,” “attempt,” “burn,” “cut,” “gun”)
  • Search strictly limited to the double-blind period
  • Subjects with events pre-dating baseline were not excluded. Events were counted if they recurred during the trial.
event adjudication
Event Adjudication
  • Adjudication of PSRAEs as per the Columbia Classification Algorithm of Suicide Assessment (C-CASA)
    • Due to the large number of subjects in the adult suicidality analysis, adjudications were performed by the sponsors and were not overseen by the FDA
  • “False positive” events identified by the text string search (e.g. gas/epigastric pain) were excluded
c casa event classification
C-CASA Event Classification

The numbering above represents a ranking of event severity, and only the most severe event per patient was submitted in the datasets