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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00292734 |
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Date of registration:
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15/02/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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STILDEP: Zolpidem in Depressive and Dysthimic Patients
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Scientific title:
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Additive Beneficial Effect of Zolpidem Onto the Antidepressant Therapy in Depressive and Dysthimic Patients in the Acute Phase of the Disease |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00292734 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Hungary
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Contacts
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Name:
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László Eros, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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sanofi-aventis Hungary |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sleep Initiation and Maintenance Disorders
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Depression
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Intervention(s)
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Drug: Zolpidem
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Primary Outcome(s)
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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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Secondary ID(s)
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EudraCT # : 2004-001967-24
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L_9259
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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