| Trial ID: | L4109 |
| Source ID: | NCT06251635
|
| Associated Drug: |
Olanzapine 2.5mg Oral Tablet
|
| Title: |
Effects of Antipsychotics on Brain Insulin Action in Females
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Insulin Resistance|Menstrual Cycle|Type 2 Diabetes|Antipsychotics
|
| Interventions: |
DRUG: Olanzapine 2.5Mg Oral Tablet|DRUG: Placebo|DRUG: Insulin Lispro 100 UNT/ML|DRUG: Saline
|
| Outcome Measures: |
Primary: Resting State Functional Connectivity (assessed through Functional MRI), Participants will complete 4 MRI scans to assess changes in resting state functional connectivity and activity across menstrual cycle phases and randomization conditions.Changes in resting state functional connectivity following intranasal insulin or placebo challenges, compared between the follicular and luteal phases of the menstrual cycle., Visits 1-4 (5-6 months); 2 visits during follicular phase, 2 visits during luteal phase. At each visit, either oral olanzapine or placebo is given. MRI #1 occurs after intranasal challenge #1 and MRI #2 occurs after intranasal challenge #2. | Secondary: Visuospatial Memory, Participants will complete the Brief Visuospatial Memory Test (BVMT) to assess visuospatial memory outcomes across the randomization conditions. BVMT Scoring: 0-36 (minimum 0, maximum 36), Visits 1-4 (5-6 months) during break between MRI scan #1 and #2.|Processing Speed, Participants will complete the Digit-Symbol Substitution Test (DSST) to assess processing speed across the randomization conditions. DSST Scoring: 0-110 (minimum 0, maximum 110), Visits 1-4 (5-6 months) during break between MRI scan #1 and #2.
|
| Sponsor/Collaborators: |
Sponsor: Centre for Addiction and Mental Health
|
| Gender: |
FEMALE
|
| Age: |
ADULT
|
| Phases: |
|
| Enrollment: |
15
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2024-06-03
|
| Completion Date: |
2026-03-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-08-01
|
| Locations: |
Centre for Addiction and Mental Health (CAMH), Toronto, Ontario, M6J 1H3, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT06251635
|
