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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 30, 2005
Last Updated Date	October 1, 2007
Start Date ^ICMJE	November 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 30, 2005)	Change from baseline to week 1 in subjective total sleep time (sTST); (average of the week one data)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00232167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 30, 2005)	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).
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With Depression
Official Title ^ICMJE	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
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.
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 ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Insomnia Depression
Intervention ^ICMJE	Drug: Indiplon Drug: Sertraline
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	380
Completion Date	April 2006
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: DSM-IV defined insomnia DSM-IV defined Major Depression Exclusion Criteria: Current suicidal ideation or behavior Primary sleep disorder other than insomnia
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00232167
Other Study ID Numbers ^ICMJE	A5761022
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Neurocrine Biosciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Neurocrine Biosciences
Verification Date	October 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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