Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232167
Recruitment Status : Terminated (Please see Detailed Description below for termination reason.)
First Posted : October 4, 2005
Last Update Posted : October 2, 2007
Information provided by:
Neurocrine Biosciences

Brief Summary:
The goal of this study is to determine whether indiplon, when administered with sertraline, improves insomnia symptoms and depressive symptoms in subjects with both insomnia and depression.

Condition or disease Intervention/treatment Phase
Insomnia Depression Drug: Indiplon Drug: Sertraline Phase 3

Detailed Description:
This Pfizer run study stopped due to the co-development program for indiplon being terminated between Pfizer and Neurocrine. The study was terminated on 16 November 2006. There were no safety issues leading to the decision to terminate this study.

Study Type : Interventional  (Clinical Trial)
Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Tolerability Of Indiplon Therapy Initiated With Sertraline Versus Sertraline Monotherapy In Subjects With Insomnia And Co-Existing Major Depressive Disorder
Study Start Date : November 2005
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Change from baseline to week 1 in subjective total sleep time (sTST); (average of the week one data)

Secondary Outcome Measures :
  1. Change from baseline in subjective total sleep time (sTST). Change from baseline in subjective parameters: LSO, sWASO, sNAASO, Sleep Quality (IVR). Change from baseline in the 3-item HAM-D insomnia factor (items #4-6).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • DSM-IV defined insomnia
  • DSM-IV defined Major Depression

Exclusion Criteria:

  • Current suicidal ideation or behavior
  • Primary sleep disorder other than insomnia Identifier: NCT00232167     History of Changes
Other Study ID Numbers: A5761022
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: October 2, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Depressive Disorder
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Hypnotics and Sedatives
Central Nervous System Depressants
GABA Modulators
GABA Agents