Obsessive Compulsive Disorder MedDRA version: 14.1 Level: LLT Classification code 10037174 Term: Psychiatric disorder NOS System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Sertraline
Product Name: Sertraline
Product Code: Generic sertraline
Pharmaceutical Form: Tablet
INN or Proposed INN: Sertra
Sponsors
Hertfordshire Partnership University NHS Foundation Trust
University of Hertfordshire
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Community based service-users, aged 18-65 years. 2) DSM-IV OCD, determined by a psychiatrist using the MINI for DSM-IV 3) Duration of symptoms >1 year (from medical history) 4) Baseline score >16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1) History of psychotic disorder (schizophrenia, psychotic symptoms, bipolar disorder), Tourette syndrome(tic disorders not amounting to Tourette syndrome will not be exclusionary), organic mental disorder, psychosurgery, personality disorder of borderline or histrionic type. 2) Alcohol/substance-abuse disorders within the past 12 months. 3) Any other DSM-IV Axis I disorder that is considered the primary focus of treatment 4) Severe depression, defined by a Montgomery-Asberg Depression Rating Scale (MADRS) >30 at baseline. 5) Actively planning suicide (scoring >4 on item 10 of MADRS)or judged by the clinician to be at significant risk of self-harm. 6) Attended CBT involving ERP from an accredited (British Association of Behavioural and Cognitive Psychotherapies (BABCP) approved or equivalent) therapist (eg. IAPTs stage 2) in the last 6 months. 7) Failed (inadequate clinical response, equivalent to =2 previous adequate (>12weeks) trials of CBT involving ERP from an accredited (BABCP-approved or equivalent) therapist. 8)Failed (inadequate clinical response,equivalent to =2 previous adequate (>12weeks) trials of any SSRI or clomipramine taken at optimal doses (if maximum SPC dose, evidence of intolerance of the higher dose is needed) with adequate adherence. 9) Needing regular psychotropic drugs other than study medication during the study (except hypnotics which will be allowed provided the dose has been stable for >12 weeks and remains so throughout the study period). 10) Currently involved in a treatment research study. 11)Acute or unstable physical illness including Hepatitis, HIV/AIDS, Creutzfeldt-Jakob disease 12) Needing regular specified medication known to interact adversely with sertraline. 13)Individual reasons making it difficult to comply with the treatment-programme, including the wash-out period. 14)Inadequate understanding of English to participate in treatment or give informed consent. 15) Women of child-bearing age not using reliable contraception. 16) Pregnant or breast-feeding women. 17) History of liver disease. 18) Epilepsy. 19) History of cardiovascular disease or blood disorders that increase bleeding tendency. eg. platelet disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main research question is to find out whether it is possible to carry out a randomised study looking at whether sertraline alone or cognitive behavioural therapy alone or a combination of both sertraline and cognitive behavioural therapy is better in treating obsessive compulsive disorder (OCD). The study will look at what obstacles there are in recruiting into a large trial, the practicality of delivering treatment and the acceptability to patients. Symptom changes, quality of life changes and resource use will also be assessed. ; Secondary Objective: Outcome measures will be evaluated. The variation in the Y-BOCS (a specific questionnaire looking at obsessions and compulsions to assess OCD severity) both within and between the three treatment arms will be evaluated. The following outcomes will also be evaluated to assess the influence on patient selection and on the change in Y-BOCS score. This will help inform the need for adjusted and stratified analysis within the large trial. The endpoints will be evaluated to enable appropriate estimation of sample size required for a full-scale trial. -Clinical Global Impression (CGI) Symptom Scale and CGI Improvement Scale (a scale to assess the clinical state of the patient) -Sheehan Disability Scale (a scale to look at how symptoms affect your life) -The Autistic Quotient (a questionnaire looking at autistic traits) -The Montgomery Asberg Depression Rating Scale -CANTAB: Stop signal reaction time; ID-ED; Affective go-no-go; Cambridge gamble task (computerised tasks to look at cogn ;Primary end point(s): The primary outcome for the study is to assess the feasibility to inform a larger clinical trial. This will be done by evaluating the number of patients willing to be randomised, evaluating the differences in methods of identifying patients, investigating premature discontinuation rates, evaluat | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following outcome measures will be evaluated to assess the influence on patient selection and on the change in Y-BOCS score which will help inform the need for adjusted and stratified analysis within the large trial. -Clinical Global Impression (CGI) Symptom Scale and CGI Improvement Scale -Sheehan Disability Scale -The Autistic Quotient -The Montgomery Asberg Depression Rating Scale -CANTAB: Stop signal reaction time; ID-ED; Affective go-no-go; Cambridge gamble task -CSRI -EQ-5D ; Timepoint(s) of evaluation of this end point: The SDS and MADRS will be evaluated at baseline, week 2, week 4, week 8, week 16, week 32 and week 52. The CGI symptom scale and AQ will be evaluated only a baseline. The EQ-5D, CSRI and CANTAB will be evaluated at baseline, week 16 and 52. The CGI improvement scale will be evaluated at weeks 2,4, 8, 16, 32 and 52. | — |
Countries
United Kingdom
Contacts
Public ContactSolange Wyatt
University of Hertfordshire
Outcome results
None listed