SchizophreniaNCT06159322
Characterizing Response to Antipsychotics in Schizophrenia
An observational study of Schizophrenia and Schizoaffective Disorder, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Olanzapine and Clozapine
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2023to 30 Jan 2024
- Phase
- Observational
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individuals with a diagnosis of schizophrenia or schizoaffective disorder
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Royal's Institute of Mental Health Research
Ottawa, Ontario, K1Z 7K4
Alexis Dorland, 613-722-6521 ext. 6952, Alexis.Dorland@theroyal.ca
About this study
Official title: A Study Investigating the Relationship Between the Antipsychotic Response and Non-invasive Proxies of Neurochemistry in Schizophrenia
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.
Read the detailed description
Currently, we cannot predict who will get better on first-line antipsychotic versus clozapine treatment. Although much evidence shows that dopamine and glutamate function are related to treatment response in schizophrenia, the utility of neuromelanin sensitive MRI (NM-MRI) as a measure of dopamine and magnetic resonance spectroscopy (MRS) as a measure of glutamate \& glycine (a co-agonist of glutamate receptors) in predicting response to treatment have never been measured in the same sample. The evidence suggests that the function of these two neurotransmitter systems partially determines the response to antipsychotic medications. Additionally, an emerging type of resting-state functional MRI (rsfMRI), naturalistic movie-watching, has been shown to outperform traditional rsfMRI for functional connectivity-based prediction of behaviour and will be explored in the current study. Given the background information, our hypotheses are:
1.1) First-line antipsychotic users will have higher dopamine turnover resulting in a higher NM-MRI signal in the substantia nigra relative to clozapine users.
1.2) First-line antipsychotic users will have lower glutamate and/or glycine concentration as indicated by the MRS signal in the dorsal anterior cingulate relative to clozapine users.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Olanzapine, Clozapine
- Keywords
- Antipsychotic treatment response
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called Zyprexa
Antipsychotic medication
ClozapineDrug
Also called Clozaril
Antipsychotic medication
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Clozapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromelanin-sensitive magnetic resonance imaging (MRI) contrast-to-noise ratio (CNR)
Indexes dopamine function
Measured: Will be examined cross-sectionally on an as-recruited basis.
Glutamate/glycine magnetic resonance sptrectroscopy (MRS)
Indexes glutamate \& glycine concentration
Measured: Will be examined cross-sectionally on an as-recruited basis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Jan 2023
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2024 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal's Institute of Mental Health Research
- Responsible party
- Sponsor
- Investigators
- Lauri Tuominen, MD, PhD, Principal investigator, The Royal's Institute of Mental Health ResearchClifford Cassidy, PhD, Principal investigator, The Royal's Institute of Mental Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159322
- Sponsor's protocol ID
- 2021033
- Status last verified
- Nov 2023
- First submitted
- 10 Apr 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Investigating the Relationship Between the Antipsychotic Response and Non-invasive Proxies of Neurochemistry in Schizophrenia
- ClinicalTrials.gov ID
- NCT06159322
- Acronym / sponsor ID
- 2021033
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Antipsychotic treatment response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Royal Ottawa Mental Health CentreUniversity, hospital or other
- Collaborators
- The Royal's Institute of Mental Health Research
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 6 Dec 2023 (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.
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.
Detailed description
Currently, we cannot predict who will get better on first-line antipsychotic versus clozapine treatment. Although much evidence shows that dopamine and glutamate function are related to treatment response in schizophrenia, the utility of neuromelanin sensitive MRI (NM-MRI) as a measure of dopamine and magnetic resonance spectroscopy (MRS) as a measure of glutamate \& glycine (a co-agonist of glutamate receptors) in predicting response to treatment have never been measured in the same sample. The evidence suggests that the function of these two neurotransmitter systems partially determines the response to antipsychotic medications. Additionally, an emerging type of resting-state functional MRI (rsfMRI), naturalistic movie-watching, has been shown to outperform traditional rsfMRI for functional connectivity-based prediction of behaviour and will be explored in the current study. Given the background information, our hypotheses are:
1.1) First-line antipsychotic users will have higher dopamine turnover resulting in a higher NM-MRI signal in the substantia nigra relative to clozapine users.
1.2) First-line antipsychotic users will have lower glutamate and/or glycine concentration as indicated by the MRS signal in the dorsal anterior cingulate relative to clozapine users.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First-line treatment group | – | Drug: OlanzapineThis 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 | – | Drug: ClozapineThis 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals with a diagnosis of schizophrenia or schizoaffective disorder
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| OlanzapineAlso: ZyprexaAntipsychotic medication | Drug | First-line treatment group |
| ClozapineAlso: ClozarilAntipsychotic medication | Drug | Treatment-resistant group |
Primary outcome
Neuromelanin-sensitive magnetic resonance imaging (MRI) contrast-to-noise ratio (CNR)
Time frame: Will be examined cross-sectionally on an as-recruited basis.
Indexes dopamine function
Glutamate/glycine magnetic resonance sptrectroscopy (MRS)
Time frame: Will be examined cross-sectionally on an as-recruited basis.
Indexes glutamate \& glycine concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No. IPD will not be shared.
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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.
Lauri Tuominen, MD, PhD principal investigator
The Royal's Institute of Mental Health Research
Clifford Cassidy, PhD principal investigator
The Royal's Institute of Mental Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder, run by The Royal Ottawa Mental Health Centre 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 5 inclusion and 8 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 6 Dec 2023. 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.
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 Lauri Tuominen, MD, PhD ((613) 722-6521 ext. 6337, Lauri.Tuominen@theroyal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. 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 6 Dec 2023.