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STILDEP: Zolpidem in Depressive and Dysthimic Patients

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00292734
First received: February 15, 2006
Last updated: December 4, 2007
Last verified: December 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Zolpidem
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Agonists
GABA-A Receptor Agonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014