The use of citalopram in treating alcoholic subtypes
ISRCTN | ISRCTN71221969 |
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DOI | https://doi.org/10.1186/ISRCTN71221969 |
Secondary identifying numbers | MCT-59634 |
- Submission date
- 26/09/2005
- Registration date
- 26/09/2005
- Last edited
- 17/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Dara Alexandra Charney
Scientific
Scientific
McGill University Health Centre
Addictions Unit
1604 Pine Avenue West
Montreal
H3G 1B4
Canada
Phone | +1 514 934 8311 |
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dara.charney@mcgill.ca |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Alcohol use disorders: clinical and biological predictors of treatment outcome |
Study objectives | Primary hypothesis: Initial treatment with citalopram improves early treatment outcome (e.g. reduces early dropouts, increases duration of abstinence, decreases number of drinking days and/or mean number of drinks per drinking day) among alcoholic patients. Secondary hypotheses: 1. Depression at intake into addiction treatment, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for a current diagnosis of major depression, is a significant positive predictor of response to citalopram (in terms of drinking-related measures), and a significant negative predictor of overall treatment outcome 2. Abnormal serotonin functioning, as measured by high 5HT uptake in platelets, and the presence of the long variant of the SERT promoter is a significant positive predictor of response to citalopram (in terms of drinking-related measures), and a significant negative predictor of overall treatment outcome As of 25/03/2009 this record was updated to include an updated anticipated end date; the initial anticipated end date was 30/09/2007. |
Ethics approval(s) | McGill University Health Centre, Clinical Trials Committee, MUHC - Montreal General Hospital, Montreal, QC gave approval on the 6th September 2002 |
Health condition(s) or problem(s) studied | Alcohol use disorders |
Intervention | Citalopram 40 mg orally (po) once a day (QD) versus placebo for 12 weeks. Both groups receive the standard addiction treatment (weekly individual and group psychotherapy) for 12 weeks. Trial details received: 12 Sept 2005 |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Citalopram |
Primary outcome measure | All planned outcomes are measured at 12 weeks, as follows: 1. Percentage change in number of drinking days 2. Percentage change in mean number of drinks per drinking day 3. Maximum duration of continuous abstinence 4. Percentage change in ASI alcohol/drug composite scores 5. Time spent in treatment (retention) 6. Time to first relapse |
Secondary outcome measures | All secondary outcomes are measured at 12 weeks: 1. Utilisation of treatment resources (e.g. number of individual/group therapy sessions attended, number of psychiatric appointments, hospitalisation, etc.) 2. Percentage change in number of drinking days 3. Percentage change in depression scores (e.g. Beck Depression Inventory [BDI], Hamilton Rating Scale for Depression [Ham-D], Symptom Checklist [SCL] subscale, etc.) 4. Percentage change in anxiety scores (e.g. Beck Anxiety Inventory [BAI], SCL subscale, etc.) 5. Percentage change in impulsivity scores (e.g. BIS total and subscales) 6. Results of random urine toxicology screening 7. Time to first relapse |
Overall study start date | 01/10/2002 |
Completion date | 01/12/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 389 |
Key inclusion criteria | 1. Women and men between 18 and 65 years of age 2. Who request treatment at the Addictions Unit 3. Who suffer from alcohol abuse or dependence (as per DSM-IV diagnostic criteria) 4. Who can be contacted reliably 5. Who have signed the consent form (as approved by the local Clinical Trials Committee) |
Key exclusion criteria | 1. If they currently suffer from another substance dependence, excluding nicotine (as per DSM-IV diagnostic criteria) 2. If they are likely to suffer severe alcohol withdrawal symptoms necessitating hospitalisation (as per American Society of Addiction Medicine guidelines for inpatient alcohol detoxification) 3. If they currently suffer from schizophrenia, schizoaffective disorder, or bipolar disorder 4. If they are currently experiencing psychotic symptoms or suicidal ideation (as determined by clinical interviews by the RA and an Addictions Unit psychiatrist) 5. If they are taking or have taken a serotonergic agent in the two weeks prior to enrolment in the study (four weeks in the case of fluoxetine) e.g. any antidepressant medication, including SSRIs, tricyclic antidepressants, MAO inhibitors, and St. Johns Wort; any mood stabilizer, including carbamazepine, lamotrigine, lithium, and valproate; any antipsychotic medication, including conventional and novel antipsychotics etc. 6. If a female patient is pregnant or breast-feeding - NB women of childbearing potential must be practicing an effective method of birth control while participating in this study, and must agree not to become pregnant during their participation in this study 7. If they have a history of serious adverse reactions or intolerance of selective serotonin reuptake inhibitors (SSRIs) |
Date of first enrolment | 01/10/2002 |
Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- Canada
Study participating centre
McGill University Health Centre
Montreal
H3G 1B4
Canada
H3G 1B4
Canada
Sponsor information
The Research Institute, McGill University Health Centre (Canada)
Research organisation
Research organisation
1650 Cedar Ave, Room S2-214
Montreal
H3G 1A4
Canada
Website | http://www.muhc.ca/ |
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https://ror.org/04cpxjv19 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-59634)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |