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

Phase 3TerminatedNCT00232167

Neurocrine Biosciences380 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

380

Conditions

Insomnia Depression

Interventions

IndiplonDRUG

SertralineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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