Semaglutide for Schizophrenia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
SchizophreniaSemaglutide - Drug
Eligibility
18 - 55
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Schizophrenia

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 15 Secondary · Reporting Duration: 32 weeks

32 weeks
1H-Magnetic resonance spectroscopy (MRS)
Arterial spin labeling (ASL)
Body Mass Index (BMI)
Change in cognitive performance
Lipids
Lifestyle assessment - Assessment of Quality of life (AQoL)
Lifestyle assessment - Food Cravings Questionnaire (FCQ);
Lifestyle assessment - International Physical Activity Questionnaire (IPAQ)
Lifestyle assessment - The Fagerstrom Test of Nicotine Dependence (FTND)
Lifestyle assessment - WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Oral glucose tolerance test
Psychopathology - Brief Psychiatric Rating Scale (BPRS)
Psychopathology - Calgary Depression Scale for Schizophrenia (CDSS)
Psychopathology - Clinical Global Impression scale (CGI)
Psychopathology - Global Assessment of Functioning (GAF)
Resting state functional MRI (rsfMRI)
Structural MRI
Visceral and hepatic adiposity
Waist circumference
Weight change

Trial Safety

Safety Progress

1 of 3

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Side Effects for

Overall Study
21%Nausea
12%Decreased Appetite
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04189848) in the Overall Study ARM group. Side effects include: Nausea with 21%, Decreased Appetite with 12%.

Trial Design

2 Treatment Groups

Semaglutide
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

92 Total Participants · 2 Treatment Groups

Primary Treatment: Semaglutide · Has Placebo Group · N/A

Semaglutide
Drug
Experimental Group · 1 Intervention: Semaglutide · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5560

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 32 weeks

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
320 Previous Clinical Trials
75,956 Total Patients Enrolled
52 Trials studying Schizophrenia
3,627 Patients Enrolled for Schizophrenia
Margaret Hahn, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
1 Previous Clinical Trials
17 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with schizophrenia, schizophreniform disorder, or schizoaffective disorder.
You are on maintenance treatment with an AP for ≥3 months.