STILDEP: Zolpidem in Depressive and Dysthimic Patients

This study has been completed.

First Received: February 15, 2006 Last Updated: December 4, 2007 History of Changes

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00292734

Purpose

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.

Condition	Intervention	Phase
Sleep Initiation and Maintenance Disorders Depression	Drug: Zolpidem	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Additive Beneficial Effect of Zolpidem Onto the Antidepressant Therapy in Depressive and Dysthimic Patients in the Acute Phase of the Disease

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Zolpidem

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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

Estimated Enrollment:	120
Study Start Date:	January 2005
Estimated Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292734

Locations

Hungary
Sanofi-aventis
Budapest, Hungary

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

László Erős, MD

sanofi-aventis Hungary

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	L_9259, EudraCT # : 2004-001967-24
Study First Received:	February 15, 2006
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00292734 History of Changes
Health Authority:	Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Zolpidem
Neurotransmitter Agents
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Depressants
Dyssomnias
Sleep Disorders
Depressive Disorder

Pharmacologic Actions
Behavioral Symptoms
Sleep Disorders, Intrinsic
Mental Disorders
Therapeutic Uses
GABA Agonists
Hypnotics and Sedatives
Mood Disorders
GABA Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010