BridgeMD
New treatment option for Insulin Resistance
Official title Effects of Antipsychotics on Brain Insulin Action in Females
ClinicalTrials.gov ID: NCT06251635
What this study is testing
What is Olanzapine 2.5Mg Oral Tablet?
Olanzapine 2.5Mg Oral Tablet is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for insulin resistance.
Also referred to as Apo-Olanzapine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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).
You likely can't join if
- 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)
- Use of weight reducing agents;
- History of kidney or liver disease;
See the full eligibility criteria
- 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).
- 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)
- Use of weight reducing agents;
- History of kidney or liver disease;
- Moderate-to-severe substance use;
- Irregular menstrual cycles (e.g., menstruation occurs less than 21 days or more than 35 days apart, or not having menstruated for three months (or 90 days), or conditions such as endometriosis or polycystic ovary...
- Current use of hormonal birth control (e.g., pill, patch, hormonal intrauterine device [IUD], ring). Participants must have had at least 2 regular menstrual cycles following the discontinuation of hormonal birth control;
- Pregnant, gave birth in the last year, or breastfeeding. Participants must have at least 3 regular menstrual cycles post-breastfeeding before beginning the study;
- Current use of progesterone, estrogen, testosterone, or fertility treatment;
- Major medical or surgical event within the last 6 months;
- Any condition that interferes with safe acquisition of MRI data such as metal implants, pacemakers, cochlear implants, claustrophobia, etc.
- Any contraindications to the investigational products as listed in the product monographs including known hypersensitivity to the drug or the excipients of the product (note: enzymatic lactose intolerance is NOT...
- Use of any of the prohibited medications listed in the product monograph of olanzapine (e.g., Levodopa and dopamine agonists and antihypertensive agents).
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.