Translational Approach to the Understanding and Treatment of Obsessive-Compulsive Disorder (OCD). Can D-Cycloserine Enhance and Stabilize the Treatment-response in Relapsed and Non-responding OCD-patients?

• Status: Completed
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

In this randomized controlled trial (RCT) the investigators experimentally test if patients with Obsessive-Compulsive Disorder (OCD) who have received treatment with exposure and response prevention (ERP), but either relapsed or not responded, profit from the combination of concentrated exposure based treatment (cET) and the NMDA-agonist (N-methyl-d-aspartate) d-cycloserine (DCS), targeting fear relevant areas in amygdala and pre-frontal cortex.

The project expects to demonstrate a significant improvement in all groups, and anticipate that a higher proportion of the patients who receive DCS will show a better long-term gain from the treatment, as compared to the placebo group at follow-up (3 mon, 12 mon, and 5 years after treatment). In addition, the project will highlight changes in depression, sleep, global functioning, quality of life, work and social status. Changes in medication and use of health care will be included and related to the main objective of the study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Haukeland University Hospital
• Collaborators: Helse Vest; The Research Council of Norway
• Treatments: Cycloserine

Criteria

All 15 OCD-teams in Norway refer patients to the study, thus providing nationwide coverage of relapsed or non-responsive OCD patients.

Through the Norwegian National OCD-implementation project all OCD-patients in Norway are ensured access to evidence based treatment. Standardized procedures for collection and storage of data (quality databases) are also established. These data will serve as reference data for standard treatment response, as well as provide detailed information regarding the first treatment-course for the relapsed OCD-patients.

The inclusion procedure implies that all relevant patients in Norway in the given time period will be offered participation. If this population turns out to be fewer than 160 patients during the study period, the inclusion period might be extended six months. If less than 160 patients are included at that point, analyses will be performed on the number of patients included by the end of the study period.

Inclusion Criteria:

• Outpatients

• ≥ 18 years

• Fulfilling diagnostic criteria of OCD according to the DSM-5

• Previously have received ERP-treatment delivered by trained therapist and either have responded and relapsed, or not responded to the treatment.

• Response is defined by ≥35% reduction with a post-treatment Y-BOCS score of ≤15, followed by a relapse as defined by > 35% increase in Y-BOCS score from post-treatment, a Y-BOCS score of 16 or more, and a Clinical Global Impression-Improvement Scale (CGI-I) score of 6 ("much worse") or higher.

• Non-responders are defined as those with a reduction in Y-BOCS scores from pre- to post-of less than 35%, and with a Y-BOCS score of ≥16 after treatment. In order to be classified as non-responder as opposed to "drop-out" the patient has to previously have received a minimum of 6 sessions.

• There must be a minimum of 4 weeks since treatment ended.

• Fluent in Norwegian

• Signed informed consent

Exclusion Criteria related to the ERP:

• OCD symptoms primarily associated with hoarding

• Ongoing substance abuse/dependence

• Bipolar disorder or psychosis

• Ongoing suicidal ideation

• Mental Retardation, based on previous medical history

• If using antidepressants:

• Not on stable dosage 12 weeks before the intervention

• Unwilling to remain on stable dosage during the four intervention days

• Unwilling to refrain from anxiolytics (e.g. benzodiazepines) and alcohol during the two days of exposure.

• Living > 1 hour drive by car/ train from the treatment location.

Exclusion Criteria related to the DCS:

• Pregnancy or breast feeding (the participants are informed that they will have to use contraception the two days when the DCS/placebo is administered. Females will be asked if they are pregnant, and in case of doubt a pregnancy test is provided)

• Renal impairment

• Hypersensitivity to D-Cycloserine

• Porphyria

• Epilepsy