Skip to main content
OpenTrials
Completed

NCT Number: NCT00368862

Efficacy Study 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Public Health Institute, Department of Mental Health and Alcohol Research

Helsinki, POB 33, 00251, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject/patient is able to read and understand the subject/patient information sheet.
  • 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.
  • Age 25-70 years
  • Heavy alcohol consumption (males more than 5 doses/ day, female more than 4 doses/day) for at least 10 years
  • Alcohol dependence (DSM-IV) assessed by SCID-I interview.
  • 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

  • Other drug dependence (screened by urine test)
  • Other serious mental illness (DSM-IV)
  • Hazard of suicide
  • Pregnancy
  • Serious kidney, hart or thyroid problem
  • The subject/patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
  • Liver cirrhosis or liver enzymes ASAT tai ALAT >200.
  • The person that met the criteria stated in the Finnish Law on Clinical Studies, paragraph 7-10§ (children, pregnant, imamates or mentally handicapped).

Treatment and study plan

Ebixa (memantine hydrochloride)

Drug

Cipralex (escitalopram)

Drug

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Finnish Institute for Health and Welfare

Other Gov

Collaborators

  • Finnish Foundation for Alcohol Studies

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2006
First posted
Aug 29, 2006
Registry last updated
Aug 29, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.