Efficacy Study of Memantine Hydrochloride and Escitalopram for the Treatment of Co-Morbid Depression and Alcoholism.
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|ClinicalTrials.gov Identifier: NCT00368862|
Recruitment Status : Completed
First Posted : August 29, 2006
Last Update Posted : August 29, 2006
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism Depression||Drug: Ebixa (memantine hydrochloride) Drug: Cipralex (escitalopram)||Phase 4|
Context Depression is common clinical problem among alcoholics and its treatment has no standard and is controversy. Glutamate NMDA-receptors may mediate the effects of long term alcohol related depression and thus the NMDA-receptor modulator memantine could have effects on it.
Objectives The preliminary aim of this study was to identify possible new treatment for depression of alcoholics and compare the efficacy of escitalopram and memantine in co-morbid depression of alcoholism.
Design and setting Double-blind, randomized, naturalistic study, 26-week trial on alcohol dependent outpatients.
Participants Eighty alcohol dependent depressive adults
Intervention Subjects were randomized 1:1 to receive memantine or escitalopram 20 mg per day. During the study the patient received routine psychosocial treatment at A-Clinic. No concomitant intervention on alcohol consumption and no imposed treatment goals. The patients were met weekly in first month, then after 3 and 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase Four Double-Blind Randomized Comparative Study on Thestudy on the Efficacy of Memantine Hydrochloride and Escitalopram for the Treatment of Co-Morbid Depression and Alcoholism|
|Study Start Date :||December 2005|
|Estimated Study Completion Date :||June 2006|
- Primary outcomes were MADRS (depression), HAM-A (anxiety), CERAD (cognitive test) and alcohol consumption (time line follow backup).
- BDI (depression), BAI (anxiety), OCDS (obsessive-compulsive drinking scale), AUDIT (alcohol use disorder identification) , and SOFAS (social and occupational functions) and quality of life measures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368862
|National Public Health Institute, Department of Mental Health and Alcohol Research|
|Helsinki, Pob 33, Finland, 00251|
|Study Director:||Hannu E Alho, MD, PhD||National Public Health Institute, Department of Mental health and Alcohol Research|