Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro
Phase 4
Completed
- Conditions
- Insomnia
- Registration Number
- NCT00296179
- Lead Sponsor
- Sanofi
- Brief Summary
To demonstrate overall improvement of insomnia in subjects treated with zolpidem tartrate extended-release (Ambien CR) and escitalopram (Lexapro) vs. subjects treated with placebo and escitalopram at 2 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 372
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Efficacy: Patient-reported TST
- Secondary Outcome Measures
Name Time Method Difference in relapse rates in patients receiving placebo and patients receiving zolpidem MR during 4 month follow-up period
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which zolpidem tartrate extended-release enhances GABAergic transmission in insomnia with depression?
How does the combination of zolpidem CR and escitalopram compare to standard-of-care antidepressants for insomnia in MDD patients?
Which biomarkers correlate with improved sleep latency and maintenance in NCT00296179 trial participants?
What are the potential adverse events associated with zolpidem CR and escitalopram combination therapy in depression?
Are there alternative hypnotic agents or combination strategies for treating insomnia in newly diagnosed MDD patients?