Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With Depression
Information source: Neurocrine Biosciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia; Depression
Intervention: Indiplon (Drug); Sertraline (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Neurocrine Biosciences
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Change from baseline to week 1 in subjective total sleep time (sTST); (average of the week one data)
Secondary outcome: 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).
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: November 2005
Ending date: April 2006
Last updated: October 1, 2007
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