NCT00292734CompletedPhase 4
Additive Beneficial Effect of Zolpidem Onto the Antidepressant Therapy in Depressive and Dysthimic Patients in the Acute Phase of the Disease
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Evaluating the effect of zolpidem and suvorexant on walking ability.NL-OMON25974CHDR18
Completed
Phase 2
This is a Study to Determine the Antidepressant Effects of AZD6765Treatment Resistant Major Depressive DisorderNCT00986479AstraZeneca22
Completed
Phase 2
The effects of a novel drug combination on sleep quality in people with sleep apnoea.Obstructive sleep apnoeaRespiratory - Sleep apnoeaACTRN12619001427167Flinders University13
Completed
Phase 2
AZD6765 for Treatment Resistant DepressionDepressionNCT00491686AstraZeneca34
Completed
Phase 4
Combining Medications to Enhance Depression OutcomesMajor Depressive DisorderNCT00590863National Institute of Mental Health (NIMH)665