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STILDEP: Zolpidem in Depressive and Dysthimic Patients

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ClinicalTrials.gov Identifier: NCT00292734
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : December 6, 2007
Sponsor:
Information provided by:
Sanofi

Brief Summary:
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 or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Depression Drug: Zolpidem Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
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
Study Start Date : January 2005
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources




Primary Outcome Measures :
  1. 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


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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

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

ClinicalTrials.gov Identifier: NCT00292734     History of Changes
Other Study ID Numbers: L_9259
EudraCT # : 2004-001967-24
First Posted: February 16, 2006    Key Record Dates
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