Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000413527
Ethics application status
Approved
Date submitted
31/08/2006
Date registered
21/09/2006
Date last updated
21/09/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment Evaluation of Alcohol and Mood
Scientific title
A double blind placebo controlled trial of citalopram for the treatment of coexisting alcohol dependence and major depressive syndrome for patients receiving naltrexone and clinical casemanagement: impact on drinking and mood symptomotology
Universal Trial Number (UTN)
Trial acronym
TEAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcoholism 1380 0
Depression 1381 0
Condition category
Condition code
Mental Health 1472 1472 0 0
Depression
Mental Health 1473 1473 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Investigate the effectiveness of 12 weeks treatment of oral citalopram (20mg daily for week one, 40mg daily during weeks 2-12, with the option to increase to 60mg daily at week six) in a group of patients being treated over the same period of time with naltrexone (25mg daily for week one, 50mg daily during weeks 2-12, with the option to increase to 100mg at week six). All patients will attend clinical case management appointments at weeks 1, 2, and 3 with appointments then every three weeks until week 24.
Intervention code [1] 1322 0
Treatment: Drugs
Comparator / control treatment
Placebo (equivalent dosage protocol)
Control group
Placebo

Outcomes
Primary outcome [1] 2040 0
The primary outcome measure for alcohol use will be the percent days abstinent
Timepoint [1] 2040 0
Measured every three weeks during the trial, with primary outcome measures at pharmacotherapy termination, and then 12 weeks and 12 months post-pharmacotherapy.
Primary outcome [2] 2041 0
The primary outcome measure for depressive symptoms will be scores on the Montgomery and Asberg Depression Rating Scale (MADRS) score.
Timepoint [2] 2041 0
Measured every three weeks during the trial, with primary outcome measures at pharmacotherapy termination, and then 12 weeks and 12 months post-pharmacotherapy.
Secondary outcome [1] 3525 0
The secondary outcome drinking measures will be based on sessional drinking data and will include mean drinks per drinking day and percentage of heavy drinking days during the follow-up period.
Timepoint [1] 3525 0
These will be measured every three weeks during the trial, with primary ouctome measures at pharmacotherapy termination, and then 12 weeks and 12 months post-pharmacotherapy.
Secondary outcome [2] 3526 0
Secondary depression outcome measures will be based on MADRS scores and Symptoms Checklist-90 (SCL-90) data, and will include catergorisation of responders and non-responders using a criterion of a MADRS score of 10 or less.
Timepoint [2] 3526 0
These will be measured every three weeks during the trial, with primary ouctome measures at pharmacotherapy termination, and then 12 weeks and 12 months post-pharmacotherapy.

Eligibility
Key inclusion criteria
Currently meets the DSM-IV (APA 1994) criteria for alcohol dependence (i.e. the presence of at least 3/7 DSM-IV criteria for alcohol dependence in the month prior to presentation; -currently meets the the DSM-IV criteria for major depression (i.e. the presence of at least 5/9 DSM-IV criteria for major depression in month prior to presentation and has no history of manic episodes);-has a MADRS score of 20 plus at presentation.
Minimum age
17 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any history of daily or nearly daily intravenous drug use for more than 2 weeks, or use of any opioid drugs in the previous 4 weeks; -a history of psychosis of any sort;-a clear history of mania or hypomania based on the DSM-IV criteria;-signifcant current risk of suicide or homicide;-severe psychiatric symptoms requiring hospitalisation;-evidence of any significant cerebral, renal, thyroid or cardiac disease;-taken disulfiram, calcium carbimide, naltrexone, or antidepressant medication during the past 4 weeks;-a history of alcoholic liver disease;-if premenopausal female: pregnancy, nursing or refusing to use a reliable method of birth control;-in prison or on home detention at any time during the past 4 weeks.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment by central randomisation (by phone). All participants are assigned a unique research number. An administrator will be responsible for applying a random list to the unique research number and then randomising patients in a double-blind fashion to receive 12 weeks of citalopram or placebo in addition to naltrexone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation by gender and primary versus secondary depression status, in blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Patients, research clinicians, senior medical officers, and investigators will all be blinded to treatment allocation. (Note: research clinicians are responsible for recruitment, assessment, casemanagement and followup).
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment outside Australia
Country [1] 389 0
New Zealand
State/province [1] 389 0

Funding & Sponsors
Funding source category [1] 1612 0
Government body
Name [1] 1612 0
Ministry of Health
Country [1] 1612 0
Funding source category [2] 1613 0
University
Name [2] 1613 0
University of Otago
Country [2] 1613 0
New Zealand
Primary sponsor type
Individual
Name
Professor Doug Sellman
Address
Country
Secondary sponsor category [1] 1415 0
Individual
Name [1] 1415 0
Karen de Zwart
Address [1] 1415 0
Country [1] 1415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3057 0
Northland District Health Board (Community Alcohol and Drug Service - Whangarei);
Ethics committee address [1] 3057 0
Ethics committee country [1] 3057 0
New Zealand
Date submitted for ethics approval [1] 3057 0
Approval date [1] 3057 0
26/04/2006
Ethics approval number [1] 3057 0
MEC/05/12/170
Ethics committee name [2] 3058 0
Waitemata District Health Board (Community Alcohol and Drug Service - Auckland);
Ethics committee address [2] 3058 0
Ethics committee country [2] 3058 0
New Zealand
Date submitted for ethics approval [2] 3058 0
Approval date [2] 3058 0
26/04/2006
Ethics approval number [2] 3058 0
MEC/05/12/170
Ethics committee name [3] 3059 0
Waikato District Health Board (Community Alcohol and Drug Service - Hamilton);
Ethics committee address [3] 3059 0
Ethics committee country [3] 3059 0
New Zealand
Date submitted for ethics approval [3] 3059 0
Approval date [3] 3059 0
26/04/2006
Ethics approval number [3] 3059 0
MEC/05/12/170
Ethics committee name [4] 3060 0
Canterbury District Health Board (Community Alcohol and Drug Service - Christchurch);
Ethics committee address [4] 3060 0
Ethics committee country [4] 3060 0
New Zealand
Date submitted for ethics approval [4] 3060 0
Approval date [4] 3060 0
26/04/2006
Ethics approval number [4] 3060 0
MEC/05/12/170
Ethics committee name [5] 3061 0
Otago District Health Board (Community Alcohol and Drug Service - Dunedin).
Ethics committee address [5] 3061 0
Ethics committee country [5] 3061 0
New Zealand
Date submitted for ethics approval [5] 3061 0
Approval date [5] 3061 0
26/04/2006
Ethics approval number [5] 3061 0
MEC/05/12/170

Summary
Brief summary
The combination of alcohol dependence and depression is very common in people presenting to alcohol and drug services. Pharmacotherapy offers a significant step forward in treatment. Effective antidepressant medications have been available for a number of decades, but medications which assist with relapse prevention in alcohol dependence (antidipsotropics), other than the long-established disulfiram, have only been developed more recently. There have been no published randomised controlled trials investigating the combination of these medications in people with both problems. This study will investigate the effectiveness of 12 weeks treatment of citalopram (an antidepressant) compared with placebo in a group of patients presenting to one of five alcohol and drug treatment clinics in New Zealand, who are all being treated over the same time period with naltrexone (an antidipsotropic) and clinical case management. They will all have both alcohol dependence and major depression. All participants will receive standard clinical case management, which will cover the initial 12 weeks of combined pharmacotherapy, followed by a further 12 weeks of active monitoring and support. This study will make an important contribution to evaluating the place of antidepressants in clinical practice for patients with co-occurring alcohol dependence and depression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27929 0
Address 27929 0
Country 27929 0
Phone 27929 0
Fax 27929 0
Email 27929 0
Contact person for public queries
Name 10511 0
Karen de Zwart
Address 10511 0
TEAM Study Co-Ordinator
National Addiction Centre
Department of Psychological Medicine
Christchurch School of Medicine & Health Sciences
University of Otago
4 Oxford Terrace
PO Box 4345
Christchurch
http://www.addiction.org.nz
Country 10511 0
New Zealand
Phone 10511 0
+64 3 3640480
Fax 10511 0
+64 3 3641225
Email 10511 0
[email protected]
Contact person for scientific queries
Name 1439 0
Professor Doug Sellman
Address 1439 0
TEAM Principal Investigator
National Addiction Centre
Department of Psychological Medicine
Christchurch School of Medicine & Health Sciences
University of Otago
4 Oxford Terrace
PO Box 4345
Christchurch
http://www.addiction.org.nz
Country 1439 0
New Zealand
Phone 1439 0
+64 3 3640480
Fax 1439 0
+64 3 3641225
Email 1439 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomized trial of combined citalopram and naltrexone for nonabstinent outpatients with co-occurring alcohol dependence and major depression.2015https://dx.doi.org/10.1097/JCP.0000000000000287
N.B. These documents automatically identified may not have been verified by the study sponsor.