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
Trial Locations
- Locations (1)
Sanofi-Aventis
🇭🇺Budapest, Hungary