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. )

First Received on September 30, 2005. Last Updated on October 1, 2007 History of Changes

Sponsor:	Neurocrine Biosciences
Information provided by:	Neurocrine Biosciences
ClinicalTrials.gov Identifier:	NCT00232167

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 III

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:

MedlinePlus related topics: Depression

Drug Information available for: Sertraline hydrochloride Sertraline Indiplon

U.S. FDA Resources

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

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
Depressive Disorder, Major
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Sertraline
Indiplon
Antidepressive Agents

Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
GABA Modulators
GABA Agents
Hypnotics and Sedatives
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 09, 2012