Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02656342 |
| Other study ID # |
2013-002574-49 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
November 2015 |
| Est. completion date |
February 2019 |
Study information
| Verified date |
February 2021 |
| Source |
Haukeland University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
A total of 160 relapsed and non-responding OCD-patients, treated with exposure and response
prevention (ERP) in the specialist Health care in Norway, are planned to participate in the
study: "Translation approach to the understanding and treatment of Obsessive-Compulsive
Disorder (OCD). Can D-cycloserine (DCS) enhance and stabilize the treatment-response in
relapsed and non-responding OCD-patients? A randomized, double-blind, placebo-controlled
national study." Estimated start of inclusion is November 2015 and the inclusion period lasts
for maximum 2 years. All participants are referred to the specialist health care and are
pre-screen by the local OCD-team. Before inclusion, the patients will fill in a number of
questionnaires on-line and all patients who meet the inclusion criteria will be invited to
participate. Before the patient signs the informed consent form the patients will receive
written and oral information about the study as well as watch a video describing the trial
and what participation will imply. Before the 4-day concentrated exposure based treatment
(cET) starts, the patients will undergo a clinical assessment interview by the local
OCD-team, and will watch another video describing the trial in detail. They will also be
assessed by SCID-I (Structured Clinical Interview) for DSM 5 as well as Y-BOCS (Yale-Brown
Obsessive Compulsive Scale) interview by independent and specially trained psychologists. The
cET is delivered in an "individual group format" which implies that the patient:
therapist-ratio is 1:1, and that the treatment is delivered in groups of minimum 3 and
maximum 6 patients. All groups are led by a specially trained cET therapist, and the local
therapists are experienced OCD-therapists who are familiar with the cET format. Day 1 of the
treatment (3 h) consists of psychoeducation and planning of exposure tasks. Day 2 and day 3
(both 8 h + contact in the evening) consist of individually tailored and therapist assisted
exposure with a number of relevant triggers in a diversity of settings. All exposures are
based on the LEaning in Technique (LET), where the patients are trained to recognize when the
urge to ritualize starts, and to actively approach the trigger by "leaning into the anxiety".
The exposures are also designed to optimize learned inhibition. In addition to individual
exposure training, the group meets three times throughout the day. Day 2 and Day 3 the
patient will take study medication before the exposures start. The study medication is
D-Cycloserine (DCS) 250 mg, DCS 100 mg or placebo. In the afternoon Day 3, the patients'
relatives/ friends are invited to a 2 h lecture/ psychoeducation on OCD and the current
treatment. Day 4 the focus is on "lessons learnt" as well as on planning / specifying
exposure tasks for the coming three weeks. Before and during the cET the patient will record
data electronically via CheckWare (an electronic case report form database). The patient will
continue registration of obsessions and compulsions through 3 weeks post cET. One week after
cET a post-assessment with Y-BOCS will be performed by the independent assessor. After 3
months, the patient is invited to an individual visit at the clinic. 1 year and 5 years post
treatment, the assessment team will perform follow-up telephone interviews.
Measures of anxiety, depression, global functioning, severity of the disorder, self-reported
OCD-symptoms, sleep, quality of life, changes in work and social status as well as changes in
medication and use of health care will be included and employed as secondary outcomes.
A total of 14 expert therapists have been trained to deliver cET to OCD-patients all over
Norway. Patients, therapists and assessors are all blinded to the randomization.
Interventions are recorded and rated for compliance and competence . All SCID-I and Y-BOCS
assessments are recorded and standard procedures for rescoring are followed. All assessors
are independent and specially trained.
A Scientific Advisory Board is established, also including representatives from the Norwegian
OCD-association. The formal project partners are Haukeland University Hospital; Oslo
University Hospital; St Olavs Hospital; Soerlandet Hospital and Moere and Romsdal Hospital.
