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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Finland

Study Type

Interventional

Intervention

Ebixa (memantine hydrochloride)

Cipralex (escitalopram)

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Alcoholism, Depression, Efficacy study, Memantine, Escitalopram

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00368862

First Posted

August 28, 2006

Last Updated

August 28, 2006

Sponsor

Finnish Institute for Health and Welfare

Collaborators

Finnish Foundation for Alcohol Studies

1. Study Identification

Unique Protocol Identification Number

NCT00368862

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2006

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Finnish Institute for Health and Welfare

Collaborators

Finnish Foundation for Alcohol Studies

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcoholism, Depression

Keywords

Alcoholism, Depression, Efficacy study, Memantine, Escitalopram

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

80 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Ebixa (memantine hydrochloride)

Intervention Type

Drug

Intervention Name(s)

Cipralex (escitalopram)

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hannu E Alho, MD, PhD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Helsinki

State/Province

Pob 33

ZIP/Postal Code

00251

Country

Finland

12. IPD Sharing Statement

Citations:

PubMed Identifier

16009352

Citation

Maler JM, Esselmann H, Wiltfang J, Kunz N, Lewczuk P, Reulbach U, Bleich S, Ruther E, Kornhuber J. Memantine inhibits ethanol-induced NMDA receptor up-regulation in rat hippocampal neurons. Brain Res. 2005 Aug 9;1052(2):156-62. doi: 10.1016/j.brainres.2005.06.017.

Results Reference

result

PubMed Identifier

18834506

Citation

Muhonen LH, Lahti J, Sinclair D, Lonnqvist J, Alho H. Treatment of alcohol dependence in patients with co-morbid major depressive disorder--predictors for the outcomes with memantine and escitalopram medication. Subst Abuse Treat Prev Policy. 2008 Oct 3;3:20. doi: 10.1186/1747-597X-3-20.

Results Reference

derived

PubMed Identifier

18348597

Citation

Muhonen LH, Lonnqvist J, Juva K, Alho H. Double-blind, randomized comparison of memantine and escitalopram for the treatment of major depressive disorder comorbid with alcohol dependence. J Clin Psychiatry. 2008 Mar;69(3):392-9. doi: 10.4088/jcp.v69n0308.

Results Reference

derived

Alcoholism, Depression

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial