rTMS in Treatment Refractory Obsessive-Compulsive Disorder

NCT02450695 | Withdrawn

• 1 other identifier: 0190
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of rTMS as a potential treatment for refractory OCD in a randomized, crossover design.

Conditions

Obsessive-Compulsive Disorder

Keywords

rTMS; treatment refractory; treatment resistant; SSRI; clomipramine

Outcome Measures

Primary Outcomes (1)

• Yale Brown Obsessive Compulsive Scale

  7 Weeks

Secondary Outcomes (4)

• Barratt Impulsiveness Scale

  7 Weeks

• Hamilton Anxiety rating Scale

  7 weeks

• Hamilton Depression Rating Scale

  7 Weeks

• Clinical Global Impression Scale

  7 Weeks

Study Arms (2)

Active rTMS

EXPERIMENTAL

In rTMS, a device called a "stimulator" provides energy to a "magnetic coil". The coil is a handheld unit that delivers magnetic pulses. The coil is placed against the scalp on the top of your head. Sessions will occur once a day, 5 days/week, for 3 weeks.

Device: rTMS

Sham rTMS

SHAM COMPARATOR

The coil in the sham rTMS phase will be positioned 90 degrees off the scalp, with one wind of the coil touching the scalp. This will ensure that the participant will not be affected by the machine during this time. All other factors will be similar to the active rTMS phase.

Device: rTMS

Interventions

rTMS DEVICE

Active rTMS; Sham rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a primary diagnosis of OCD (DSM 5) according to the MINI
• Y-BOCS score of ≥20
• History of treatment-resistant OCD, established by a trained psychiatrist with extensive expertise in the OCD field. Treatment-resistance will be defined as non-response to at least two SRIs trials (clomipramine, fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, escitalopram).

You may not qualify if:

• Any additional current psychiatric comorbidity, except for mild depressive and anxious symptoms
• A lifetime DSM-5 diagnosis of schizophrenia or other psychotic syndromes, substance dependence or substance abuse, including alcohol, bipolar I or II disorder, mental disorder due to a general medical condition
• Serious suicide risk
• Episodic OCD
• Illness duration less than two years
• Hospitalization in the last 6 months
• Pharmacological treatment changes in the last 3 months
• The inability to receive rTMS because of metallic implants, or history of seizures (personal or family history of seizure in first degree relatives)
• Any major medical disease
• Pregnancy or nursing of an infant
• The inability or refusal to provide informed consent
• Prior TMS exposure (in order to reduce the risk of unblinding).
• No psychotherapy and/or pharmacological treatment changes will be allowed during the study period. Pharmacologically treated patients should be on constant medications for at least 2 weeks before entering the study.

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

MacAnxiety Research Center

Hamilton, Ontario, L8S 1B7, Canada

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Michael Van Ameringen, MD, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 21, 2015
• Study Start: July 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

CA (1)