STILDEP: Zolpidem in Depressive and Dysthimic Patients

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Zolpidem

Criteria

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