SchizophreniaPhase 2/3NCT03413527
rTMS Treatment for Positive and Negative Symptoms of Schizophrenia
A Phase 2/3 study testing rTMS in people with Schizophrenia, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Feb 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N3K7
Sheila Verhage-Brown, HBSc, MD
About this study
Official title: Examining the Impact of Transcranial Magnetic Stimulation (rTMS) on Schizophrenia and Related Disorders: A Case Series
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.
- Conditions
- Schizophrenia
- Being tested
- rTMS
- Keywords
- rTMS
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
rTMS Treatment
| Study group | Role | What they receive |
|---|---|---|
| rTMS Treatment | Experimental | Not described Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from pre-treatment to post treatment over 6 weeks
Secondary outcomes (2)
Beck Depression Inventory
Self-report questionnaire for depression symptoms. Scores range from 0-63, with higher being worse.
Measured: Change from pre-treatment to post treatment over 6 weeks
Hamilton Depression Rating Scale (HAM-D)
Clinician-rated scale for depression symptoms. Scores range from 0-53, with higher being worse.
Measured: change from pre-treatment to post treatment over 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study startFeb 2016
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Chaimowitz, St. Joseph's Healthcare Hamilton
- Investigators
- Gary Chaimowitz, MD, FRCPC, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413527
- Sponsor's protocol ID
- 3864
- Status last verified
- Apr 2019
- First submitted
- 17 Jan 2018
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Transcranial Magnetic Stimulation (rTMS) on Schizophrenia and Related Disorders: A Case Series
- ClinicalTrials.gov ID
- NCT03413527
- Acronym / sponsor ID
- 3864
- Conditions
- Schizophrenia
- Keywords
- rTMS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS Treatment | Experimental | Device: rTMS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSrTMS Treatment | Device | rTMS Treatment |
Primary outcome
Positive and Negative Symptom Scale (PANSS)
Time frame: Change from pre-treatment to post treatment over 6 weeks
semi-structured interview designed to rate the severity of schizophrenia symptoms. Score from 0-231, with higher score being worse.
2 secondary outcomes
Beck Depression Inventory
Time frame: Change from pre-treatment to post treatment over 6 weeks
Hamilton Depression Rating Scale (HAM-D)
Time frame: change from pre-treatment to post treatment over 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Chaimowitz, MD, FRCPC principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing rTMS in people with Schizophrenia, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheila Verhage-Brown, HBSc, MD (905-522-1155 ext. 36356, sverhage@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Symptom Scale (PANSS) (time frame: Change from pre-treatment to post treatment over 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.