Antidepressants and suicidality in adults data overview
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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

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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

Antidepressants studied

Antidepressants Studied

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

Trial disposition

Trial Disposition

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

Dataset variables

Dataset Variables

Dataset variables1

Dataset Variables

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