Status:
COMPLETED
STILDEP: Zolpidem in Depressive and Dysthimic Patients
Lead Sponsor:
Sanofi
Conditions:
Sleep Initiation and Maintenance Disorders
Depression
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 antidepressa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00292734
Start Date
January 1 2005
End Date
June 1 2006
Last Update
December 6 2007
Active Locations (1)
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1
Sanofi-Aventis
Budapest, Hungary