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

Depression Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00232167
• Other study ID #: A5761022
• Status: Terminated
• Phase: Phase 3
• First received: September 30, 2005
• Last updated: October 1, 2007
• Start date: November 2005
• Est. completion date: April 2006

Study information

• Verified date: October 2007
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 380
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• DSM-IV defined insomnia

• DSM-IV defined Major Depression

Exclusion Criteria:

• Current suicidal ideation or behavior

• Primary sleep disorder other than insomnia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Insomnia

Intervention

Drug:
• Indiplon

• Sertraline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 1 in subjective total sleep time (sTST); (average of the week one data)
Secondary	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).