Recruiting

Antipsychotics

Sponsor:

The Royal Ottawa Mental Health Centre

Code:

NCT06159322

Conditions

Schizophrenia

Schizoaffective Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Olanzapine

Clozapine

Study Details

Brief summary:

The goal of this research project is to develop MRI-based biomarkers to identify patients with schizophrenia who are most likely to benefit from first-line antipsychotic or clozapine treatment. The MRI sequences (NM-MRI, MRS and rsfMRI) will be created by translating the best scientific evidence into a potential clinical product that has the highest chance of being clinically relevant predictor of treatment response. This study has the potential to significantly improve patient outcomes and reduce unnecessary interventions and costs at the Royal's Integrated Schizophrenia Recovery Program.

Conditions

Schizophrenia

Schizoaffective Disorder

Study ID

NCT06159322

Start date

Jan 1, 2023

Status verified date

Nov, 2023

Completion date

Jan 30, 2024

Anticipated

Primary completion date

Jan 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Are voluntary and competent to consent to the study
  • Are between the ages of 18-55
  • Are English literate
  • Have a diagnosis of schizophrenia or schizoaffective disorder
  • Are currently taking primarily olanzapine or clozapine

Exclusion Criteria:

  • Medication for the treatment of schizophrenia or schizoaffective disorder has changed in the past month
  • Have a significant neurologic, neurodevelopmental, cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, or metabolic-endocrine disorder
  • Are pregnant or breastfeeding
  • Acquire positive urine test result for all drugs of abuse including cannabis
  • Have met DSM-5 criteria for substance use disorder other than tobacco in the last 6 months
  • Have a history of significant head trauma with loss of consciousness for more than 5 minutes
  • Have any contraindication to MRI
  • Have any other condition that in the opinion of the investigator(s) could create a hazard to the subject's safety, endanger the study procedures, or interfere with the interpretation of study results

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

First-line treatment group

This group will consist of 20 patients with schizophrenia or schizoaffective disorder who are primarily prescribed olanzapine. Treatment will be carried out by the physicians within their circle of care, however, we will record their symptoms as they continue treatment.

Treatment-resistant group

This group will consist of 20 patients with schizophrenia or schizoaffective disorder who are primarily prescribed clozapine due to poor treatment response to first-line antipsychotic agents. Treatment will be carried out by the physicians within their circle of care, however, we will record their symptoms as they continue treatment.

Interventions

Olanzapine

Antipsychotic medication

Clozapine

Antipsychotic medication

Primary outcome measure

  • Neuromelanin-sensitive magnetic resonance imaging (MRI) contrast-to-noise ratio (CNR) [ Time Frame: Will be examined cross-sectionally on an as-recruited basis. ]
  • Glutamate/glycine magnetic resonance sptrectroscopy (MRS) [ Time Frame: Will be examined cross-sectionally on an as-recruited basis. ]

Central Contacts and Locations

Central contacts

Lauri Tuominen, MD, PhD

(613) 722-6521Lauri.Tuominen@theroyal.ca

Coleka Masama, BSc

(613) 722-6521coleka.masama@theroyal.ca

Locations

The Royal's Institute of Mental Health Research

Recruiting

Ottawa, Ontario, Canada, K1Z 7K4

Contacts

Alexis Dorland

613-722-6521Alexis.Dorland@theroyal.ca

More Information

Sponsor

The Royal Ottawa Mental Health Centre

Last update posted

Dec 6, 2023

Last verified

Nov, 2023

Keywords

  • Antipsychotic treatment response

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Royal Ottawa Mental Health Centre on 2023-12-06.