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Antipsychotic

Follicular Phase Visits for Antipsychotics

Q: Are individuals aged 70 and above eligible to participate in this trial?

To be considered for this study, individuals must be at least 18 years old but no older than 35.

Q: Is it possible for me to participate in this research trial?

To qualify for participation in this research study, individuals must exhibit insulin resistance and fall within the age range of 18 to 35 years. Approximately 15 candidates will be accepted into the trial.

Q: What is the current number of individuals who have been granted admission to participate in this clinical study?

Indeed, the information provided on clinicaltrials.gov indicates that this particular clinical study is presently in search of suitable participants. The trial's initial posting date was February 28th, 2024, with the most recent update occurring on February 1st, 2024. This investigation aims to enroll a total of 15 individuals from one designated site.

N/A

Recruiting

Led By Mahavir Agarwal, MBBS, PhD, MD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: 18-35 years

Body Mass Index (BMI) <25 kg/m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

Study Summary

This trial seeks to understand how antipsychotic medications may affect brain insulin action in females, especially during different phases of their menstrual cycle. The study will involve giving young healthy females olanzapine

Who is the study for?

This trial is for young healthy females who may be experiencing insulin resistance, type 2 diabetes, or menstrual irregularities and are not currently on antipsychotics. Participants should be able to undergo MRI scans and have no history of drug abuse, psychiatric disorders, or significant medical conditions.Check my eligibility

What is being tested?

The study tests how the brain's response to insulin in females is affected by their menstrual cycle phase and the use of an antipsychotic called Olanzapine. It involves giving participants intranasal insulin or a placebo during different phases of their menstrual cycle while monitoring changes with MRI.See study design

What are the potential side effects?

Olanzapine can cause weight gain, increased appetite, drowsiness, and sometimes more serious side effects like changes in metabolism. Intranasal insulin has few reported side effects but might include irritation inside the nose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 35 years old.

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My BMI is less than 25.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Resting State Functional Connectivity (assessed through Functional MRI)

Secondary outcome measures

Processing Speed

Visuospatial Memory

Trial Design

2Treatment groups

Experimental Treatment

Group I: Luteal Phase VisitsExperimental Treatment4 Interventions

Participants will undergo two visits during the luteal phase of the menstrual cycle (they will be scanned between day 16-22, or within 5 days of next expected menses depending on individual cycle duration). Each of the study periods will involve administration of OLA 5 mg HS (or PL) on day 0, OLA 10 mg HS (or PL) on day 1, and cognitive testing and MRI scanning on day 2. MRI assessments will occur 15 minutes after administering 160 International Units (IU) INI/INP.

Group II: Follicular Phase VisitsExperimental Treatment4 Interventions

Participants will undergo two visits during the follicular phase of the menstrual cycle (they will be scanned between day 4-10 of their menstrual cycle). Each of the study periods will involve administration of OLA 5 mg HS (or PL) on day 0, OLA 10 mg HS (or PL) on day 1, and cognitive testing and MRI scanning on day 2. MRI assessments will occur 15 minutes after administering 160 International Units (IU) INI/INP.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Saline

2013

Completed Phase 4

~1050

Insulin Lispro 100 UNT/ML

2017

Completed Phase 2

~50

Placebo

1995

Completed Phase 3

~2670

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor

356 Previous Clinical Trials

81,443 Total Patients Enrolled

Mahavir Agarwal, MBBS, PhD, MDPrincipal InvestigatorCentre for Addiction and Mental Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 70 and above eligible to participate in this trial?

"To be considered for this study, individuals must be at least 18 years old but no older than 35."

Answered by AI

Is it possible for me to participate in this research trial?

"To qualify for participation in this research study, individuals must exhibit insulin resistance and fall within the age range of 18 to 35 years. Approximately 15 candidates will be accepted into the trial."

Answered by AI

What is the current number of individuals who have been granted admission to participate in this clinical study?

"Indeed, the information provided on clinicaltrials.gov indicates that this particular clinical study is presently in search of suitable participants. The trial's initial posting date was February 28th, 2024, with the most recent update occurring on February 1st, 2024. This investigation aims to enroll a total of 15 individuals from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Antipsychotics on Brain Insulin Action in Females

2024. "Effects of Antipsychotics on Brain Insulin Action in Females". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06251635.

All > Womens Health