Characterizing Response to Antipsychotics in Schizophrenia

NCT06159322 | Unknown DMC

• 1 other identifier: 2021033
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Antipsychotic treatment response

Outcome Measures

Primary Outcomes (2)

• Neuromelanin-sensitive magnetic resonance imaging (MRI) contrast-to-noise ratio (CNR)

  Indexes dopamine function

  Will be examined cross-sectionally on an as-recruited basis.

• Glutamate/glycine magnetic resonance sptrectroscopy (MRS)

  Indexes glutamate \& glycine concentration

  Will be examined cross-sectionally on an as-recruited basis.

Study Arms (2)

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.

Drug: Olanzapine

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.

Drug: Clozapine

Interventions

Olanzapine DRUG

Antipsychotic medication

Also known as: Zyprexa

First-line treatment group

Clozapine DRUG

Antipsychotic medication

Also known as: Clozaril

Treatment-resistant group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with a diagnosis of schizophrenia or schizoaffective disorder

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Ottawa Mental Health Centre: lead
• The Royal's Institute of Mental Health Research: collaborator

Study Sites (1)

The Royal's Institute of Mental Health Research

Ottawa, Ontario, K1Z 7K4, Canada

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Olanzapine; Clozapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring

Study Officials

• Lauri Tuominen, MD, PhD

  The Royal's Institute of Mental Health Research

  PRINCIPAL INVESTIGATOR

• Clifford Cassidy, PhD

  The Royal's Institute of Mental Health Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauri Tuominen, MD, PhD

CONTACT

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

Coleka Masama, BSc

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: December 6, 2023
• Study Start: January 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)