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Semaglutide for Schizophrenia and Obesity (Sema Trial)
Sema Trial Summary
This trial will investigate whether semaglutide, a weight-loss drug, is effective in reducing body weight in overweight or obese individuals with schizophrenia-spectrum disorders who are on antipsychotic medications and do not demonstrate adequate weight loss on metformin.
Sema Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 104 Patients • NCT04189848Sema Trial Design
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- I have diabetes, with an HbA1c level over 6.5%.You have a serious addiction to drugs or alcohol, except for tobacco or caffeine. Only severe addiction to cannabis would exclude you from participating.I have had pancreatitis or high amylase levels.I am taking medication for weight loss, blood thinning, or that affects my kidneys.I have liver or kidney problems.My BMI is over 30, or over 27 with a weight-related health issue, or over 25 and I've gained more than 5% of my weight due to AP treatment.I have a history of blood sugar dropping suddenly.I have been on a stable dose of antipsychotic medication for over 3 months.I or my family have a history of thyroid cancer or multiple endocrine neoplasia.I have a history of heart rhythm problems.I have a thyroid condition that is not well-managed.I have not had a major medical or surgical event in the last 3 months.You are currently at high risk for attempting suicide.I am a woman of childbearing age not using birth control, nursing, or pregnant.I haven't taken GLP-1RA in the last 3 months or couldn't tolerate it.I have a serious heart, blood, lung, or hormone-related condition that is not under control.I am 18-65 years old with schizophrenia, major depression with psychosis, or bipolar disorder.I couldn't lose 5% of my weight on metformin over 16 weeks and haven't taken it for at least a week.I have a severe stomach or intestine disease.I have a history of gallstones or am at risk for gallbladder issues, and my gallbladder has not been removed.
- Group 1: Semaglutide
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is recruitment for this trial still open?
"This medical trial, which initially appeared on the clinicaltrials.gov platform in late May 2022 is presently recruiting participants. The latest update to this protocol was issued at the end of June that same year."
How many participants is the organization recruiting for this trial?
"Affirmative. According to clinicaltrials.gov, this medical experiment is still open for enrollment since its debut on May 25th 2022 and has been updated as recently as June 27th 2022. In total, the trial requires 92 participants from a single location."
What population is eligible to participate in this clinical experiment?
"This clinical trial is in search of 92 patients aged 18 to 55 with neuromyelitis optica. To be eligible, applicants must meet the following criteria: stable outpatients between ages 18 and 55 diagnosed with schizophrenia or schizoaffective disorder; a BMI ≥30 kg/m2 or higher, or 27 kg/m2 if there are any weight-related comorbidities (treated or untreated) such as hypertension, dyslipidaemia, obstructive sleep apnea, and impaired fasting glucose; unsuccessful attempts at losing 5% bodyweight over three months on metformin treatment; and ongoing maintenance therapy (>9 months"
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