Effects of Antipsychotics on Brain Insulin Action in Females

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorCentre for Addiction and Mental Health

About this trial

Females treated with antipsychotics have higher rates of comorbid metabolic syndrome than males. Despite this, females have historically been excluded from many mechanistic studies due to confounding effects of menstrual cycles. Recent evidence suggests that brain insulin resistance may be an underlying mechanism through which antipsychotics may exert their metabolic side effects. This study seeks to investigate how brain insulin action differs in females according to their menstrual cycle phase, and how a high metabolic liability agent such as olanzapine might interrupt these differential insulin effects. Young healthy females will be given olanzapine and intranasal insulin to test how these treatment combinations change brain processes. Participants will be tested during both the first half of their menstrual cycle (follicular phase) and the second half of their cycle (luteal phase). The investigators predict that intranasal insulin will change MRI-based measures in females, in a comparable way to males, in the follicular phase only. Adding olanzapine will block these effects of insulin in females in the follicular phase. This investigation has the potential to generate new knowledge in an area of significant unmet need. Demonstrating that antipsychotics disrupt brain insulin action, evidenced by inhibition of recognized effects of insulin on neuroimaging measures, will provide novel insights into currently poorly understood mechanisms.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 18-35 years

Body Mass Index (BMI) between 18.5 - 24.9 kg/m2

Normal menstrual cycle (defined as cycle length ranging from 21 to 35 days over the past 6 months).

Disqualifiers

History of psychiatric illness (screened using the Mini International Neuropsychiatric Interview (MINI));

Pre-diabetes or diabetes (fasting glucose ≥6.0 mmol/L, HbA1c>6% or use of anti-diabetic drug);

Evidence of impaired insulin sensitivity, assessed using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) ≥2.5;

Family history of diabetes in a first degree relative (parent or sibling)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Olanzapine 2.5Mg Oral Tablet

    Drug

    Olanzapine capsules (2.5mg) will be administered during one research visit for each menstrual cycle phase. The dosing schedule is as follows: 1. Day 0- 5mg 2. Day 1- 10mg

  • Placebo

    Drug

    Placebo capsules visually identical to those containing olanzapine will be administered according to the same dosing schedule during one research visit of each menstrual cycle phase.

  • Insulin Lispro 100 UNT/ML

    Drug

    At each visit, participants will be given an intranasal insulin challenge (160 IU) to assess brain insulin signalling via MRI based assay.

  • Saline

    Drug

    At each visit, participants will be given an intranasal saline placebo (1.6 mL) in order to establish baseline brain insulin signalling via MRI based assay.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: Follicular Phase VisitsExperimental treatment 4 interventions
Group B: Luteal Phase VisitsExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
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 outcomes

1

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)

Time frame
Visits 1-4 (5-6 months) during break between MRI scan #1 and #2.
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)

Time frame
Visits 1-4 (5-6 months) during break between MRI scan #1 and #2.

Other outcomes

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