Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278246
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-15
Brief Title:
Investigating the Muscarinic System in Schizophrenia Using Positron Emission Tomography
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
The Muscarinic Hypothesis of Schizophrenia An 11CMK-6884 PET Study Study Protocol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Within the schizophrenia population there are individuals that respond to first-line antipsychotic treatments while others do not The availability of muscarinic M4 subtype receptors M4R may play a role as to whether a person with schizophrenia is responsive to first-line antipsychotics or not The goal of this observational study is to compare the availability of M4R in antipsychotic-free patients with schizophrenia and matched healthy controls In addition M4R availability in schizophrenia patients will be examined in relation to response to first line antipsychotics and clinical and cognitive measures This study may help better understand antipsychotic resistance in schizophrenia and lead to the development of new treatment options particularly for cognitive deficits and negative symptoms
Detailed Description:
This study is composed of two participant groups 1 Antipsychotic-free patients with schizophrenia and 2 healthy matched controls The healthy controls will be matched as closely as possible for age sex cannabis and nicotine consumption to the patient group All participants will undergo a positron emission tomography PET scan to measure the M4R binding with 11CMK-6884 and examine its relationship with clinical and cognitive measures
Participants who meet the inclusion and exclusion criteria at screening visit visit 1 will be enrolled into the study All participants will undergo a PET scan with the novel tracer 11CMK-6884 to examine its binding with M4R The third visit will consist of a MRI scan and cognitive assessments Participants with schizophrenia will have visit four which occurs 6 weeks after the first antipsychotic trial initiated by their treating physician If the treating physician starts a second antipsychotic trial then a visit five occurs 6 weeks after the second trial Both visits four and five involve clinical and cognitive assessments
Participants who meet the inclusion and exclusion criteria at screening visit visit 1 will be enrolled into the study All participants will undergo a PET scan with the novel tracer 11CMK-6884 to examine its binding with M4R The third visit will consist of a MRI scan and cognitive assessments Participants with schizophrenia will have visit four which occurs 6 weeks after the first antipsychotic trial initiated by their treating physician If the treating physician starts a second antipsychotic trial then a visit five occurs 6 weeks after the second trial Both visits four and five involve clinical and cognitive assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None