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STILDEP: Zolpidem in Depressive and Dysthimic Patients

Primary Purpose

Sleep Initiation and Maintenance Disorders, Depression

Status
Completed
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
Zolpidem
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
February 15, 2006
Last Updated
December 4, 2007
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00292734
Brief Title
STILDEP: Zolpidem in Depressive and Dysthimic Patients
Official Title
Additive Beneficial Effect of Zolpidem Onto the Antidepressant Therapy in Depressive and Dysthimic Patients in the Acute Phase of the Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zolpidem
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
László Erős, MD
Organizational Affiliation
sanofi-aventis Hungary
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Budapest
Country
Hungary

12. IPD Sharing Statement

Learn more about this trial

STILDEP: Zolpidem in Depressive and Dysthimic Patients

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