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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:
Information provided by:
Neurocrine Biosciences
ClinicalTrials.gov Identifier:
NCT00232167
First received: September 30, 2005
Last updated: October 1, 2007
Last verified: October 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00232167     History of Changes
Other Study ID Numbers: A5761022
Study First Received: September 30, 2005
Last Updated: October 1, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Indiplon
Sertraline
Antidepressive Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014