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

This study has been terminated.
(Please see Detailed Description below for termination reason.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00232167
First Posted: October 4, 2005
Last Update Posted: October 3, 2007
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.
Information provided by:
Neurocrine Biosciences
  Purpose
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 Intervention Phase
Insomnia Depression Drug: Indiplon Drug: Sertraline Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Neurocrine Biosciences:

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

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 380
Study Start Date: November 2005
Estimated Study Completion Date: April 2006
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

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

Exclusion Criteria:

  • Current suicidal ideation or behavior
  • Primary sleep disorder other than insomnia
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00232167     History of Changes
Other Study ID Numbers: A5761022
First Submitted: September 30, 2005
First Posted: October 4, 2005
Last Update Posted: October 3, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Depression
Depressive Disorder
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Sertraline
Indiplon
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