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Brain Stimulation for Schizophrenia

N/A

Recruiting

Led By Philip Gerretsen, MD, PhD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

DSM-V diagnosis of SCZ or schizoaffective disorder

Be older than 18 years old

Must not have

Unwilling or incapable to consent to the study based on the MacArthur Test of Competence

Unstable medical or any concomitant major medical or neurological illness, including a history of seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during 3-month follow up phase

Summary

This trial will explore whether a non-invasive brain stimulation called transcranial direct current stimulation (tDCS) can help improve adherence to antipsychotic medication in people with schizophrenia.

Who is the study for?

This trial is for adults with schizophrenia or schizoaffective disorder who are on a stable medication regimen and can consent to participate. It's not for pregnant individuals, those with certain learning difficulties, severe thought disorders, recent substance dependence (except caffeine/nicotine), metal implants/pacemakers, acute suicidal/homicidal thoughts, or other major medical/neurological illnesses.

What is being tested?

The study tests transcranial direct current stimulation (tDCS) as an additional treatment to help patients with schizophrenia stick to their antipsychotic medication schedule. Participants will receive either the active tDCS or a sham (fake) version in 20 sessions to compare effects on medication adherence.

What are the potential side effects?

While tDCS is generally considered safe, potential side effects may include mild itching, tingling or discomfort at the electrode site during stimulation. There might also be fatigue or headache after the session but serious side effects are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with schizophrenia or schizoaffective disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give consent for the study.

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I do not have any major illnesses or a history of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during 3-month follow up phase

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during 3-month follow up phase

This trial's timeline: 3 weeks for screening, Varies for treatment, and during 3-month follow up phase for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Medication adherence - Clinician Rating

Medication adherence - Pill Count

Medication adherence - Plasma Monitoring

Secondary study objectives

Insight into Psychosis

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active TDCSExperimental Treatment1 Intervention

In the active condition, a constant current of 2 mA intensity will be applied for 20 min to the parietal regions, using P3 as the cathode and P4 as the anode.

Group II: Sham TDCSPlacebo Group1 Intervention

In the sham condition, stimulation will be administered using the same parameters at the site of active treatment, but the current will be turned off after 30 seconds.

0 / 3Eligibility criteria met