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iTBS-DCS in Obsessive Compulsive Disorder

NCT05177601 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2023-09-13

No results posted yet for this study

Summary

Obsessive Compulsive Disorder (OCD)is a common and debilitating illness. For an unacceptable proportion of patients, depressive symptoms remain impairing despite multiple treatments.

In August 2018, the FDA approved transcranial magnetic stimulation (TMS) for the treatment of OCD based on a large study demonstrating efficacy. Our neurophysiological data and clinical data in depression suggests that we can enhance the effects of TMS by using an adjunctive medication called D-Cyloserine (DCS, 100mg) in conjunction with stimulation. The mechanism by which this is achieved is called synaptic plasticity, or the activity dependent changes that occur with brain stimulation.

Research Question and Objectives: To conduct a randomized sham- and placebo-controlled trial of DCS in adjunct with rTMS in OCD. Participants will be randomized to receive 100mg of DCS or placebo together with TMS.

Conditions

  • Obsessive-Compulsive Disorder

Interventions

DEVICE

iTBS repetitive Transcranial Magnetic Stimulation (rTMS)

rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of mood disorders.

DEVICE

Sham rTMS

Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.

DRUG

D-cycloserine

Daily oral D-cycloserine 100mg during TMS treatments (20 days).

DRUG

Placebo oral capsule

Daily oral placebo during the TMS treatments (20 days).

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Alexander McGirr, MD, PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-26
Primary Completion
2024-10-31
Completion
2025-10-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05177601 on ClinicalTrials.gov