rTMS in Treatment Refractory Obsessive-Compulsive Disorder

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02450695
• Date of registration: 19/05/2015
• Prospective Registration: Yes
• Primary sponsor: McMaster University
• Public title: rTMS in Treatment Refractory Obsessive-Compulsive Disorder
• Scientific title: A Randomized Crossed-over Trial Examining Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in Treatment Refractory Obsessive-Compulsive Disorder.
• Date of first enrolment: July 2016
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02450695
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Michael Van Ameringen, MD, FRCPC
• Affiliation: McMaster University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obsessive-Compulsive Disorder

Intervention(s)

Device: rTMS

Primary Outcome(s)

Yale Brown Obsessive Compulsive Scale [Time Frame: 7 Weeks]

Secondary Outcome(s)

Hamilton Anxiety rating Scale [Time Frame: 7 weeks]

Barratt Impulsiveness Scale [Time Frame: 7 Weeks]

Hamilton Depression Rating Scale [Time Frame: 7 Weeks]

Clinical Global Impression Scale [Time Frame: 7 Weeks]

Secondary ID(s)

0190

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hamilton Health Sciences Corporation

St. Joseph's Healthcare Hamilton