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STILDEP: Zolpidem in Depressive and Dysthimic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00292734
First Posted: February 16, 2006
Last Update Posted: December 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


Further study details as provided by Sanofi:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292734


Locations
Hungary
Sanofi-Aventis
Budapest, Hungary
Sponsors and Collaborators
Sanofi
Investigators
Study Director: László Erős, MD sanofi-aventis Hungary
  More Information

ClinicalTrials.gov Identifier: NCT00292734     History of Changes
Other Study ID Numbers: L_9259
EudraCT # : 2004-001967-24
First Submitted: February 15, 2006
First Posted: February 16, 2006
Last Update Posted: December 6, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action