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

Neurocrine Biosciences

Status and phase: Terminated; Phase 3

Conditions: Insomnia; Depression

Treatments: Drug: Sertraline; Drug: Indiplon

Study type: Interventional

Funder types: Industry

Identifiers

NCT00232167

A5761022

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind