Condition category
Mental and Behavioural Disorders
Date applied
22/04/2015
Date assigned
22/04/2015
Last edited
22/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Himanshu Tyagi

ORCID ID

Contact details

UCL Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13158

Study information

Scientific title

Deep brain stimulation for severe obsessive compulsive disorder: Efficacy and mechanisms of ventral striatum and subthalamic nucleus targets

Acronym

Study hypothesis

The overarching aim is to compare the effects of VC/VS and STN DBS in the same patients. We will test the hypothesis, grounded in cognitive neuroscience, that DBS at both sites is better than either site alone for treating the symptom dimensions of OCD. Specifically, we will employ novel cognitive paradigms and neurophysiological measures of cortical synaptic function to test the hypothesis that VS/VC and STN DBS have different mechanisms of action and that alleviation of OCD symptoms is mediated by improvement in mood/anxiety with VS/VC DBS and by directly interrupting obsessions and compulsions with STN DBS. We will additionally determine whether adjunctive CBT enhances the response to DBS by providing the cognitive and behavioural skills to optimise symptom management and daily function.

Ethics approval

12/LO/1087

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Topic: Mental Health; Subtopic: Personality disorder; Disease: Personality disorders

Intervention

1. Cognitive Behavioural Therapy: CBT for OCD including Graded Exposure and Self Imposed Response Prevention.
2. Deep Brain Stimulation: A neurosurgical procedure involving the implantation of a medical device in brain.
Study Entry : Single Randomisation only

Intervention type

Other

Phase

Drug names

Primary outcome measures

YBOCS improvement greater than or equal to 35%; Timepoint(s): 15 months

Secondary outcome measures

N/A

Overall trial start date

22/01/2013

Overall trial end date

31/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

The inclusion criteria have been designed to be consistent with previous OCD DBS studies and to ensure that patients have not responded in a useful and sustained manner to either modifications of medication or any form of CBT.
1. Patients must have undergone intensive treatment and have demonstrable treatment resistance as defined by:
1.1. At least two SRIs for a minimum of 12 weeks at optimal British National Formulary (BNF) doses
1.2.Augmentation of SRI treatment with antipsychotic drugs administered at maximally tolerated doses or by extending the SSRI dose beyond BNF limits
1.3. Two trials of CBT of at least 10 hours
1.4. Failed inpatient treatment.
2. Patients must also satisfy the following criteria:
2.1. Age > 20 years
2.2. Confirmation of a primary diagnosis of obsessive compulsive disorder (ICD10 F42.0—F42.9);
2.3. Duration of illness of at least 10 years
2.4. At least 2 years of unremitting symptoms despite intensive psychopharmacological and psychological treatment or failure to sustain, over a 3 month period, a response to inpatient psychological treatment by at least 33% with accompanying optimised pharmacological therapy
2.5. A minimum score of 32 on Yale Brown Obsessive Compulsive Scale (YBOCS 22) thus constituting profound illness and a maximum score of 50 on the DSM IV General Assessment of Function Scale (GAF)
2.6. Ability to provide sustained informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 6; UK Sample Size: 6

Participant exclusion criteria

1. Current diagnoses of substance misuse (ICD10 F10—F19), organic brain syndrome (ICD10 F00—F09), adult personality disorder (ICD10 F60—F69), pervasive developmental disorder (ICD10 F84); schizophrenia (ICD10 F20-F29) and bipolar disorder (ICD 10 F30-31)
2. Contraindications to neurosurgery
3. Pregnancy

Recruitment start date

22/01/2013

Recruitment end date

31/08/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UCL Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Medical Research Council (Grant Codes: MR/J012009/1)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes