STILDEP: Zolpidem in Depressive and Dysthimic Patients
Phase 4
Completed
- Conditions
- Sleep Initiation and Maintenance DisordersDepression
- Registration Number
- NCT00292734
- Lead Sponsor
- Sanofi
- Brief Summary
Primary objective: To show that the combination of Zolpidem + antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Depressive and dysthimic patients in acute phase of mild to moderate severity
- Depressive and dysthimic patients suffering from secondary insomnia (DSM IV) recent antidepressant therapy (less than 1 week)
Exclusion Criteria
- Regularly use of sleeping pills in the last 2-3 month
- Use of any sleeping pils in the last week
- Insufficient hepatic
- Myasthenia gravis
- Proven hypersensivity to Zolpidem
- Evidence of clinically relevant nervous system disorders (other neurologic/psychiatric diseases associated with depression)
- History of evidence of alcohol or drug abuse
- Evidence of clinically relevant cardiovascular, haematologic, hepatic, gastrointestinal, renal, pulmonary or endocrinologic diseases
- Abnormal snore
- Work an alternating shift
- Suffering from periodic leg movement disorder and sleep apnea
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method To show that the combination of Stilnox+ antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease
- Secondary Outcome Measures
Name Time Method
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 molecular mechanisms underlie Zolpidem's additive effect on antidepressant therapy for secondary insomnia in depression?
How does Zolpidem combination therapy compare to standard-of-care treatments for sleep initiation and maintenance disorders in major depressive disorder?
Are there specific biomarkers that predict response to Zolpidem adjunctive therapy in dysthymic patients with secondary insomnia?
What are the potential adverse events associated with Zolpidem when used as an adjunct to antidepressants in acute depression phases?
What alternative GABAergic compounds or combination approaches are being explored for treating secondary insomnia in depressive disorders?
Trial Locations
- Locations (1)
Sanofi-Aventis
🇭🇺Budapest, Hungary
Sanofi-Aventis🇭🇺Budapest, Hungary