- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00368862
Efficacy Study of Memantine Hydrochloride and Escitalopram for the Treatment of Co-Morbid Depression and Alcoholism.
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Pob 33
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Helsinki, Pob 33, Finland, 00251
- National Public Health Institute, Department of Mental Health and Alcohol Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Primary outcomes were MADRS (depression), HAM-A (anxiety), CERAD (cognitive test) and alcohol consumption (time line follow backup).
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Secondary Outcome Measures
Outcome Measure |
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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.
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Hannu E Alho, MD, PhD, National Public Health Institute, Department of Mental Health and Alcohol Research
Publications and helpful links
General 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. doi: 10.1016/j.brainres.2005.06.017.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Chemically-Induced Disorders
- Alcohol-Related Disorders
- Substance-Related Disorders
- Mood Disorders
- Alcoholism
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agents
- Antidepressive Agents, Second-Generation
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Citalopram
- Memantine
Other Study ID Numbers
- KTL172-9
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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