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CompletedNCT00368862Updated Aug 29, 2006

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

A Phase 4 interventional study of Ebixa (memantine hydrochloride) and Cipralex (escitalopram) in Alcoholism and Depression, sponsored by Finnish Institute for Health and Welfare. Completed at 1 site in Finland. Open to participants aged 25 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-08-29.

Sponsored by Finnish Institute for Health and Welfare · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
25 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Alcoholism
  • Depression

Keywords

  • Alcoholism
  • Depression
  • Efficacy study
  • Memantine
  • Escitalopram
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In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 80 is close to the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Finnish Institute for Health and Welfare is the lead sponsor of 43 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
80 participants

Interventions

  • DrugEbixa (memantine hydrochloride)
  • DrugCipralex (escitalopram)
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What researchers measure

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.

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Study locations

1 site
  • National Public Health Institute, Department of Mental Health and Alcohol Research
    Helsinki, Pob 33 00251, Finland
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References and documents

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. PubMed 16009352 ↗
  • 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. PubMed 18834506 ↗
  • 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. PubMed 18348597 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00368862
Lead sponsor
Finnish Institute for Health and Welfare
Collaborators
Finnish Foundation for Alcohol Studies
First posted
Aug 29, 2006
Start date
Dec 2005
Completion
Jun 2006
Last update
Aug 29, 2006

Study contacts

Hannu E Alho, MD, PhD
study director · National Public Health Institute, Department of Mental health and Alcohol Research
View the source record on ClinicalTrials.gov ↗

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