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

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

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.

Inclusion Criteria:

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

Exclusion Criteria:

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