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Efficacy Study of Memantine Hydrochloride and Escitalopram for the Treatment of Co-Morbid Depression and Alcoholism.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00368862
Recruitment Status : Completed
First Posted : August 29, 2006
Last Update Posted : August 29, 2006
Finnish Foundation for Alcohol Studies
Information provided by:
National Institute for Health and Welfare, Finland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcoholism Depression Drug: Ebixa (memantine hydrochloride) Drug: Cipralex (escitalopram) Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Completion Date : June 2006

Primary Outcome Measures :
  1. Primary outcomes were MADRS (depression), HAM-A (anxiety), CERAD (cognitive test) and alcohol consumption (time line follow backup).

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT00368862

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National Public Health Institute, Department of Mental Health and Alcohol Research
Helsinki, Pob 33, Finland, 00251
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Finnish Foundation for Alcohol Studies
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Study Director: Hannu E Alho, MD, PhD National Public Health Institute, Department of Mental health and Alcohol Research

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00368862     History of Changes
Other Study ID Numbers: KTL172-9
First Posted: August 29, 2006    Key Record Dates
Last Update Posted: August 29, 2006
Last Verified: August 2006
Keywords provided by National Institute for Health and Welfare, Finland:
Efficacy study
Additional relevant MeSH terms:
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Muscarinic Antagonists
Cholinergic Antagonists
Excitatory Amino Acid Antagonists
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents