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?

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.

Conditions

• Obsessive-Compulsive Disorder

Interventions

DRUG

D-Cycloserine

Predicted to enhance stabilization of the effects of concentrated exposure treatment

DRUG

Placebo

Predicted to have no enhancing effect

Sponsors & Collaborators

• The Research Council of Norway

  collaborator OTHER

• Helse Vest

  collaborator OTHER

• Haukeland University Hospital

  lead OTHER

Principal Investigators

• Gerd Kvale · Haukeland University Hospital

• Bjarne Hansen · Haukeland University Hospital

• Michelle Craske, PhD · Haukeland University Hospital

• Jonathan Abramowitz, PhD · Haukeland University Hospital

• Hime A Joeseph, PhD · Haukeland University Hospital

• Martin D Franklin, PhD · Haukeland University Hospital

• Michael Davis, PhD · Haukeland University Hospital

• Lars-Göran Öst, PhD · Haukeland University Hospital

• Odile van den Heuvel, PhD · Haukeland University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2018-09-30

Completion

2019-02-28

Countries

• Norway

Study Locations