STILDEP: Zolpidem in Depressive and Dysthimic Patients
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep Initiation and Maintenance Disorders; Depression
Intervention: Zolpidem (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
László Erős, MD, Study Director, Affiliation: sanofi-aventis Hungary
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.
Clinical Details
Official title: Additive Beneficial Effect of Zolpidem Onto the Antidepressant Therapy in Depressive and Dysthimic Patients in the Acute Phase of the Disease
Study design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Primary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Sanofi-Aventis, Budapest, Hungary
Additional Information
clinicalstudyresults.org
Starting date: January 2005
Ending date: June 2006
Last updated: December 4, 2007
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