STILDEP: Zolpidem in Depressive and Dysthimic Patients

Depression Clinical Trial

Official title:

Additive Beneficial Effect of Zolpidem Onto the Antidepressant Therapy in Depressive and Dysthimic Patients in the Acute Phase of the Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292734
• Other study ID #: L_9259
• Secondary ID: EudraCT # : 2004
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2006
• Last updated: December 4, 2007
• Start date: January 2005
• Est. completion date: June 2006

Study information

• Verified date: December 2007
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Zolpidem

Locations

Country	Name	City	State
Hungary	Sanofi-Aventis	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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