STILDEP: Zolpidem in Depressive and Dysthimic Patients

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Hungary

Study Type

Interventional

Intervention

Zolpidem

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

NCT ID

NCT00292734

First Posted

February 15, 2006

Last Updated

December 4, 2007

Sponsor

Sanofi

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

Sleep Initiation and Maintenance Disorders, Depression

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial