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

Sponsor:	National Institute for Health and Welfare, Finland
Collaborator:	Finnish Foundation for Alcohol Studies
Information provided by:	National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:	NCT00368862

Purpose

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	Intervention	Phase
Alcoholism Depression	Drug: Ebixa (memantine hydrochloride) Drug: Cipralex (escitalopram)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Alcoholism Anxiety Depression

Drug Information available for: Benzetimide Memantine Dexetimide Memantine hydrochloride Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by National Institute for Health and Welfare, Finland:

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.

Estimated Enrollment:	80
Study Start Date:	December 2005
Estimated Study Completion Date:	June 2006

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.

Eligibility

Ages Eligible for Study:	25 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368862

Locations

Finland
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

Investigators

Study Director:

Hannu E Alho, MD, PhD

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

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Muhonen LH, Lahti J, Sinclair D, Lönnqvist 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.

Muhonen LH, Lönnqvist 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.

ClinicalTrials.gov Identifier:	NCT00368862 History of Changes
Other Study ID Numbers:	KTL172-9
Study First Received:	August 28, 2006
Last Updated:	August 28, 2006
Health Authority:	Finland: Finnish Medicines Agency

Keywords provided by National Institute for Health and Welfare, Finland:

Alcoholism
Depression
Efficacy study
Memantine
Escitalopram

Additional relevant MeSH terms:

Alcoholism
Depression
Depressive Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders
Dexetimide
Memantine
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012