STILDEP: Zolpidem in Depressive and Dysthimic Patients

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.

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Budapest, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zolpidem

Drug

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Study completion: 2006
First posted: Feb 16, 2006
Registry last updated: Dec 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed