Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With Depression
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|ClinicalTrials.gov Identifier: NCT00232167|
Recruitment Status : Terminated (Please see Detailed Description below for termination reason.)
First Posted : October 4, 2005
Last Update Posted : October 2, 2007
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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|
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|
|Intervention Model:||Parallel Assignment|
|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|
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).
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