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

Phase 3

Terminated

• Conditions: Insomnia; Depression

• Registration Number: NCT00232167
• Lead Sponsor: Neurocrine Biosciences

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 Timeline

• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Study First Posted: 2005-10-04
• Study Start: 2005-11
• Study Completion: 2006-04
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-01
• Last Update Posted: 2007-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

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

Exclusion Criteria

• Current suicidal ideation or behavior
• Primary sleep disorder other than insomnia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline to week 1 in subjective total sleep time (sTST); (average of the week one data)

Secondary Outcome Measures

Name	Time	Method
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).