AlcoholismPhase 4NCT00368862
Efficacy Study of Memantine Hydrochloride and Escitalopram for the Treatment of Co-Morbid Depression and Alcoholism.
A Phase 4 study testing Ebixa (memantine hydrochloride) and Cipralex (escitalopram) in people with Alcoholism and Depression, run by Finnish Institute for Health and Welfare at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism, Depression
- What is being tested?
- Ebixa (memantine hydrochloride) and Cipralex (escitalopram)
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2005to Jun 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Finland1 site
National Public Health Institute, Department of Mental Health and Alcohol Research
Helsinki, POB 33, 00251
About this study
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
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.
- Conditions
- Alcoholism, Depression
- Being tested
- Ebixa (memantine hydrochloride), Cipralex (escitalopram)
- Keywords
- Alcoholism, Depression, Efficacy study, Memantine, Escitalopram
- Medical subject headings
- Alcoholism, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ebixa (memantine hydrochloride)Drug
Cipralex (escitalopram)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startDec 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Finnish Foundation for Alcohol Studies
- Investigators
- Hannu E Alho, MD, PhD, Study director, National Public Health Institute, Department of Mental health and Alcohol Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368862
- Sponsor's protocol ID
- KTL172-9
- Status last verified
- Aug 2006
- First submitted
- 28 Aug 2006
- Last updated
- 29 Aug 2006
- Results posted
- No
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 16009352Muhonen 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 18834506Muhonen 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00368862
- Acronym / sponsor ID
- KTL172-9
- Conditions
- Alcoholism, Depression
- Keywords
- Alcoholism, Depression, Efficacy study, Memantine, Escitalopram
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Finnish Foundation for Alcohol Studies
- Study start
- Dec 2005
- Study completion
- Jun 2006
- First posted
- 29 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Other drug dependence (screened by urine test)
- Other serious mental illness (DSM-IV)
- Hazard of suicide
- Pregnancy
- Serious kidney, hart or thyroid problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ebixa (memantine hydrochloride) | Drug | – |
| Cipralex (escitalopram) | Drug | – |
Primary outcome
Primary outcomes were MADRS (depression), HAM-A (anxiety), CERAD (cognitive test) and alcohol consumption (time line follow backup).
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2006.
- Results publication: PubMed 16009352Maler 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.
- Derived from this study: PubMed 18834506Muhonen 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.
- Derived from this study: PubMed 18348597Muhonen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannu E Alho, MD, PhD study director
National Public Health Institute, Department of Mental health and Alcohol Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ebixa (memantine hydrochloride) and Cipralex (escitalopram) in people with Alcoholism and Depression, run by Finnish Institute for Health and Welfare at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcomes were MADRS (depression), HAM-A (anxiety), CERAD (cognitive test) and alcohol consumption (time line follow backup).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00368862, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2006.