Status:

WITHDRAWN

Is There a New Gold Standard for the Treatment of Obsessive-Compulsive Disorder?

Lead Sponsor:

University of Alberta

Conditions:

Obsessive-Compulsive Disorder

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief Summary

Obsessive Compulsive Disorder is a highly debilitating condition with a lifetime prevalence of 2%-3%, and a notable percentage of patients (40-60%) have a partial or no response to medications. The pr...

Detailed Description

i. Purpose a) The purpose of this study is to compare and evaluate the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) by MagVenture and Deep Transcranial Magnetic Stimulation (DTMS) ...

Eligibility Criteria

Inclusion

  • i. Outpatients ii. Men and women 18-70 years of age. iii. Patients diagnosed as suffering from OCD according to the BOCS and YBOCs. iv. Patients had an inadequate/intolerable response to SSRI, CBT (Exposure and Response Prevention) or both.
  • v. Patient is capable and willing to provide informed consent, and their guardians is capable of providing informed consent.
  • vi. Patient is able to adhere to the treatment schedule.

Exclusion

  • i. Present suicidal risk is significant as assessed during the investigator's mental status exam and psychiatric interview.
  • ii. Patient has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT) or history of such in first-degree relatives.
  • iii. Patient has an increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure, or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes.
  • iv. Patient has a history of head injury necessitating cranial surgery or prolonged coma.
  • v. Patient has ferromagnetic material in the head including the eyes and ears (outside the mouth) and body.
  • vi. Patient has a history of significant hearing loss. vii. Patients with significant neurological disorder or insult including, but not limited to:
  • Any condition likely to be associated with increased intracranial pressure
  • Space occupying brain lesion
  • History of cerebrovascular accident
  • Transient ischemic attack within two years
  • Cerebral aneurysm
  • Dementia
  • Parkinson's disease
  • Huntington's chorea
  • Multiple sclerosis
  • Mini Mental State Exam score of less than or equal to 24 (for adult participants) viii. Patient has a history of substance abuse including alcohol use disorder within the past 6 months (except nicotine and caffeine).
  • ix. Inadequate communication with the patient. x. Patient is currently participating in another clinical study or enrolled in another clinical study within 30 days prior to this study.
  • xi. Patients who suffer from an unstable physical, systemic and metabolic disorder such as unstable blood pressure or acute, unstable cardiac disease.
  • xii. Women who are pregnant or with suspected pregnancy

Key Trial Info

Start Date :

July 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2022

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04436952

Start Date

July 1 2020

End Date

July 1 2022

Last Update

July 18 2022

Active Locations (1)

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Envision Mind Care

Edmonton, Alberta, Canada, T6W 2Z8