Optimal Treatment for Obsessive Compulsive Disorder Trial

Phase 1

• Conditions: Obsessive Compulsive Disorder; MedDRA version: 14.1 Level: LLT Classification code 10037174 Term: Psychiatric disorder NOS System Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-003219-22-GB
• Lead Sponsor: Hertfordshire Partnership University NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-02
• Study Completion: 2017-07-17
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 49

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

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 <25% improvement) >=2 previous adequate (>12weeks) trials of CBT involving ERP from an accredited (BABCP-approved or equivalent) therapist.
8)Failed (inadequate clinical response,equivalent to <25% improvement) >=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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified