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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Insomnia Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Indiplon

Intervention Type DRUG

Sertraline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* DSM-IV defined insomnia
* DSM-IV defined Major Depression

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Countries

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United States

Other Identifiers

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A5761022

Identifier Type: -

Identifier Source: org_study_id