Depression, Sleep Initiation and Maintenance Disorders
Conditions
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.
Interventions
DRUGZolpidem
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Hungary
Outcome results
None listed