STILDEP: Zolpidem in Depressive and Dysthimic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Initiation and Maintenance Disorders Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Zolpidem

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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László Erős, MD

Role: STUDY_DIRECTOR

sanofi-aventis Hungary

Locations

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Sanofi-Aventis

Budapest, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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EudraCT # : 2004-001967-24

Identifier Type: -

Identifier Source: secondary_id

L_9259