The use of citalopram in treating alcoholic subtypes

ISRCTN	ISRCTN71221969
DOI	https://doi.org/10.1186/ISRCTN71221969
Protocol serial number	MCT-59634
Sponsor	The Research Institute, McGill University Health Centre (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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

McGill University Health Centre
Addictions Unit
1604 Pine Avenue West
Montreal
H3G 1B4
Canada

Phone	+1 514 934 8311
Email	dara.charney@mcgill.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Citalopram
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan