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Efficacy Study of Memantine Hydrochloride and Escitalopram for the Treatment of Co-Morbid Depression and Alcoholism.
This study has been completed.
Study NCT00368862   Information provided by National Institute for Health and Welfare, Finland
First Received: August 28, 2006   No Changes Posted

August 28, 2006
August 28, 2006
December 2005
 
Primary outcomes were MADRS (depression), HAM-A (anxiety), CERAD (cognitive test) and alcohol consumption (time line follow backup).
Same as current
No Changes Posted
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.
Same as current
 
Efficacy Study of Memantine Hydrochloride and Escitalopram for the Treatment of Co-Morbid Depression and Alcoholism.
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

The aim of the present study was to examine the influence of memantine, a noncompetitive NMDA receptor blocker, in depression co-morbid with long term alcohol heavy use comparing to SSRI-inhibitor, escitalopram. Second goal is to compare their influence to cognitive tasks and the third goal is to follow up alcohol-use with these two medicines.

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.

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
  • Alcoholism
  • Depression
  • Drug: Ebixa (memantine hydrochloride)
  • Drug: Cipralex (escitalopram)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
80
June 2006
 

Inclusion Criteria:

  1. The subject/patient is able to read and understand the subject/patient information sheet.
  2. Prior to any screening procedures, the subject/patient must have signed the informed consent form. No study-related procedures may be performed before the subject/patient has signed the form.
  3. Age 25-70 years
  4. Heavy alcohol consumption (males more than 5 doses/ day, female more than 4 doses/day) for at least 10 years
  5. Alcohol dependence (DSM-IV) assessed by SCID-I interview.
  6. Major depression (DSM-IV) assessed by SCID-I interview. At least 4 weeks past from the previous inpatient treatment for AWS (alcohol withdrawal syndrome).

Exclusion Criteria:

  1. Other drug dependence (screened by urine test)
  2. Other serious mental illness (DSM-IV)
  3. Hazard of suicide
  4. Pregnancy
  5. Serious kidney, hart or thyroid problem
  6. The subject/patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
  7. Liver cirrhosis or liver enzymes ASAT tai ALAT >200.
  8. The person that met the criteria stated in the Finnish Law on Clinical Studies, paragraph 7-10§ (children, pregnant, imamates or mentally handicapped).
Both
25 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00368862
 
KTL172-9
National Institute for Health and Welfare, Finland
Finnish Foundation for Alcohol Studies
Study Director: Hannu E Alho, MD, PhD National Public Health Institute, Department of Mental health and Alcohol Research
National Institute for Health and Welfare, Finland
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP