Study Stopped
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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
1 other identifier
interventional
380
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2005
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedOctober 2, 2007
October 1, 2007
September 30, 2005
October 1, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline to week 1 in subjective total sleep time (sTST); (average of the week one data)
Secondary Outcomes (1)
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).
Interventions
Eligibility Criteria
You may qualify if:
- DSM-IV defined insomnia
- DSM-IV defined Major Depression
You may not qualify if:
- Current suicidal ideation or behavior
- Primary sleep disorder other than insomnia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
November 1, 2005
Study Completion
April 1, 2006
Last Updated
October 2, 2007
Record last verified: 2007-10