NCT03413527

Brief Summary

This study will examine the effects of rTMS on the negative and positive symptoms of schizophrenia using 2 treatments in sequence applied to related brain areas.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2 schizophrenia

Timeline
Completed

Started Feb 2016

Longer than P75 for phase_2 schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

4 years

First QC Date

January 17, 2018

Last Update Submit

April 18, 2019

Conditions

Schizophrenia

Keywords

rTMS

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Symptom Scale (PANSS)

    semi-structured interview designed to rate the severity of schizophrenia symptoms. Score from 0-231, with higher score being worse.

    Change from pre-treatment to post treatment over 6 weeks

Secondary Outcomes (2)

  • Beck Depression Inventory

    Change from pre-treatment to post treatment over 6 weeks

  • Hamilton Depression Rating Scale (HAM-D)

    change from pre-treatment to post treatment over 6 weeks

Study Arms (1)

rTMS Treatment

EXPERIMENTAL
Device: rTMS

Interventions

rTMSDEVICE

rTMS Treatment

rTMS Treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • are voluntary and competent to consent to treatment
  • have a diagnosis of schizophrenia or schizoaffective disorder
  • are between the ages of 18 and 75
  • are willing and able to adhere to the treatment schedule
  • Pass the TMS adult safety-screening (TASS) questionnaire
  • have normal thyroid functioning based on pre-study blood work. Patients may be reassessed for the study once thyroid levels have normalized.
  • are willing and able to cooperate with interviews and follow simple instructions

You may not qualify if:

  • do not pass the TASS Safety Screening Questionnaire
  • have a significant history of seizures
  • have active suicidal intent
  • are pregnant or may be pregnant. A pregnancy test will be performed for fertile women.
  • have failed a course of Electroconvulsive Therapy (ECT) in the current or previous episode
  • have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, or head trauma resulting in loss of consciousness greater than or equal to 5 minutes
  • have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
  • have had changes in dose or initiation of any psychotropic medication in the 4 weeks prior to screening. Patients may be re-screened once medications have been stable for 4 weeks.
  • currently (or in the last 4 weeks) take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N3K7, Canada

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Gary Chaimowitz, MD, FRCPC

    St. Joseph's Healthcare Hamilton

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila Verhage-Brown, HBSc, MD

CONTACT

905-522-1155sverhage@stjoes.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Head of Forensics Service

Study Record Dates

First Submitted

January 17, 2018

First Posted

January 29, 2018

Study Start

February 1, 2016

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

April 22, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)