NCT00368862

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2006

Completed
Last Updated

August 29, 2006

Status Verified

August 1, 2006

First QC Date

August 28, 2006

Last Update Submit

August 28, 2006

Conditions

AlcoholismDepression

Keywords

AlcoholismDepressionEfficacy studyMemantineEscitalopram

Outcome Measures

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.

Interventions

Ebixa (memantine hydrochloride)DRUG
Cipralex (escitalopram)DRUG

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Helsinki, POB 33, 00251, Finland

Location

Related Publications (3)

  • 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.

    PMID: 16009352RESULT

  • 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.

    PMID: 18834506DERIVED

  • 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.

    PMID: 18348597DERIVED

MeSH Terms

Conditions

AlcoholismDepression

Interventions

MemantineDexetimideEscitalopram

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropylaminesAminesNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Hannu E Alho, MD, PhD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 28, 2006

First Posted

August 29, 2006

Study Start

December 1, 2005

Study Completion

June 1, 2006

Last Updated

August 29, 2006

Record last verified: 2006-08

Locations

FI(1)