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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368862
• Other study ID #: KTL172-9
• Status: Completed
• Phase: Phase 4
• First received: August 28, 2006
• Last updated: August 28, 2006
• Start date: December 2005
• Est. completion date: June 2006

Study information

• Verified date: August 2006
• Source: National Institute for Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Depression
• Depressive Disorder

Intervention

Drug:
• Ebixa (memantine hydrochloride)

• Cipralex (escitalopram)

Locations

Country	Name	City	State
Finland	National Public Health Institute, Department of Mental Health and Alcohol Research	Helsinki	Pob 33

Sponsors (2)

Lead Sponsor	Collaborator
National Institute for Health and Welfare, Finland	Finnish Foundation for Alcohol Studies

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcomes were MADRS (depression), HAM-A (anxiety), CERAD (cognitive test) and alcohol consumption (time line follow backup).
Secondary	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.