Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder
NCT ID: NCT00807248
Last Updated: 2012-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
490 participants
INTERVENTIONAL
2008-11-30
2010-02-28
Brief Summary
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Detailed Description
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* placebo or
* escitalopram 20 mg/day or
* escitalopram 20 mg/day in combination with gaboxadol 5 mg/day or
* escitalopram 20 mg/day in combination with gaboxadol 10 mg/day
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Escitalopram placebo and gaboxadol placebo
Escitalopram placebo
Once daily before bedtime for 8 weeks
Gaboxadol placebo
Once daily before bedtime for 8 weeks
Escitalopram 20 mg and gaboxadol placebo
Gaboxadol placebo
Once daily before bedtime for 8 weeks
Escitalopram 20 mg
Once daily before bedtime for 8 weeks
Escitalopram 20 mg and gaboxadol 5 mg
Escitalopram 20 mg
Once daily before bedtime for 8 weeks
Gaboxadol 5 mg
Once daily before bedtime for 8 weeks
Escitalopram 20 mg and gaboxadol 10 mg
Escitalopram 20 mg
Once daily before bedtime for 8 weeks
Gaboxadol 10 mg
Once daily before bedtime for 8 weeks
Interventions
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Escitalopram placebo
Once daily before bedtime for 8 weeks
Gaboxadol placebo
Once daily before bedtime for 8 weeks
Escitalopram 20 mg
Once daily before bedtime for 8 weeks
Gaboxadol 5 mg
Once daily before bedtime for 8 weeks
Gaboxadol 10 mg
Once daily before bedtime for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With reported duration of the current major depressive episode of at least 3 months
* With MADRS total score of at least 30
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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AT001
Vienna, , Austria
RU019
Barnaul, , Russia
RU029
Izhevsk, , Russia
RU020
Kemerovo, , Russia
RU012
Krasnodar, , Russia
RU010
Krasnodar, , Russia
RU022
Kursk, , Russia
RU015
Moscow, , Russia
RU026
Moscow, , Russia
RU001
Moscow, , Russia
RU002
Moscow, , Russia
RU028
Moscow, , Russia
RU003
Moscow, , Russia
RU007
Moscow, , Russia
RU027
Saransk, , Russia
RU024
Saratov, , Russia
RU013
Saratov, , Russia
RU021
Tomsk, , Russia
RU016
Tver', , Russia
RU014
Volgograd, , Russia
RU011
Yaroslavl, , Russia
RU018
Yekaterinburg, , Russia
Countries
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References
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Kasper S, Ebert B, Larsen K, Tonnoir B. Combining escitalopram with gaboxadol provides no additional benefit in the treatment of patients with severe major depressive disorder. Int J Neuropsychopharmacol. 2012 Jul;15(6):715-25. doi: 10.1017/S146114571100112X. Epub 2011 Oct 19.
Other Identifiers
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2008-000506-36
Identifier Type: REGISTRY
Identifier Source: secondary_id
12213A
Identifier Type: -
Identifier Source: org_study_id