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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