Status:
COMPLETED
Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To compare the efficacy of escitalopram fixed dose 20 mg/day in combination with fixed doses of gaboxadol (5 and 10 mg/day) versus escitalopram fixed dose 20 mg/day after 8 weeks of treatment in patie...
Detailed Description
Subjects participating in this study will be respectively randomised (1:2:2:2) to receive either: * placebo or * escitalopram 20 mg/day or * escitalopram 20 mg/day in combination with gaboxadol 5 mg/...
Eligibility Criteria
Inclusion
- Clinical Diagnosis of MDD according to DSM-IV-TR criteria:
- With reported duration of the current major depressive episode of at least 3 months
- With MADRS total score of at least 30
Exclusion
- The patient has 1 or more of the following:
- Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR
- Current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR
- Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR
- Presence or history of a clinically significant neurological disorder (including epilepsy)
- Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc)
- Any Axis II disorder that might compromise the study
- Previous use of hallucinogenic drug
- The patient has a significant risk of suicide according to the investigator's opinion, or has a score \>=5 on item 10 (suicidal thoughts) of the MADRS, or has made a suicide attempt in the previous 12 months.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT00807248
Start Date
November 1 2008
End Date
February 1 2010
Last Update
December 17 2012
Active Locations (22)
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1
AT001
Vienna, Austria, 1090
2
RU019
Barnaul, Russia, 656022
3
RU029
Izhevsk, Russia, 426054
4
RU020
Kemerovo, Russia, 650036