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

Primary Purpose

Insomnia, Depression

Status

Terminated

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Indiplon

Sertraline

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: DSM-IV defined insomnia DSM-IV defined Major Depression Exclusion Criteria: Current suicidal ideation or behavior Primary sleep disorder other than insomnia

Sites / Locations

Outcomes

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).

Full Information

NCT ID

NCT00232167

First Posted

September 30, 2005

Last Updated

October 1, 2007

Sponsor

Neurocrine Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT00232167

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Terminated

Why Stopped

Please see Detailed Description below for termination reason.

Study Start Date

November 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Neurocrine Biosciences

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia, Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

380 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Indiplon

Intervention Type

Drug

Intervention Name(s)

Sertraline

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Learn more about this trial

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

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