STILDEP: Zolpidem in Depressive and Dysthimic Patients

Sanofi120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Sleep Initiation and Maintenance Disorders Depression

Interventions

ZolpidemDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 (1)

Sanofi-Aventis

Budapest, Hungary

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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