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Bromocriptine for Schizophrenia and Diabetes-Related Issues

Phase 4
Waitlist Available
Led By Ronald Codario, M.D.
Research Sponsored by VA Pittsburgh Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female participants must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control until the study is complete
Either fasting glucose of 100 to 125 mg/dL inclusive and/or an A1C in the range between 5.7-6.4%
Must not have
Historical or current diagnosis of diabetes mellitus (type 1, type 2, or other)
Pregnant or breast feeding. Women of child-bearing potential must be surgically-sterile or using reliable methods of birth control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at weeks 0, 1, 2, 4, 6, 8, and 10 (weeks 8 and 10 are two and four weeks after study drug discontinuation)
Awards & highlights

Summary

This trial is testing whether bromocriptine, a drug that affects dopamine and serotonin levels, is a safe and tolerable way to improve glucose tolerance and insulin resistance in people with schizophrenia who are also taking antipsychotic drugs.

Who is the study for?
This trial is for adults aged 18-65 with schizophrenia and impaired glucose tolerance, who have been on second-generation antipsychotic meds for at least 3 months without dose changes. Participants must not be pregnant, have a BMI of at least 30 kg/m2, and no history of diabetes or violent behavior. They should agree to use birth control and provide emergency contact information.
What is being tested?
The study tests the safety and tolerability of bromocriptine as an add-on treatment for patients with schizophrenia taking antipsychotics that may cause blood sugar issues. It aims to see if this drug can prevent or delay type 2 diabetes by improving insulin resistance over a six-week period.
What are the potential side effects?
Potential side effects include nausea, dizziness, headache, fatigue, constipation or diarrhea. Since bromocriptine affects dopamine receptors in the brain it might also lead to mood swings or unusual body movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant and agree to use birth control during the study.
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My blood sugar or A1C levels are slightly elevated but not diabetic.
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I've been on a stable dose of a second generation antipsychotic for 3 months.
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I am between 18 and 65 years old and have been diagnosed with schizophrenia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with diabetes.
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I am not pregnant or breastfeeding and use reliable birth control or am surgically sterile.
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I have a liver or kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at weeks 0, 1, 2, 4, 6, 8, and 10 (weeks 8 and 10 are two and four weeks after study drug discontinuation)
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at weeks 0, 1, 2, 4, 6, 8, and 10 (weeks 8 and 10 are two and four weeks after study drug discontinuation) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
HOMA-IR
Secondary study objectives
Abnormal Involuntary Movement Scale (AIMS)
Clinical Global Impression
Columbia-Suicide Severity Rating Scale (C-SSRS)
+4 more

Side effects data

From 2019 Phase 2 trial • 108 Patients • NCT02544321
31%
nausea
10%
orthostasis
5%
headache
2%
fatigue
2%
severe hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo (Adults)
Bromocriptine QR (Adolescents)
Bromocriptine QR (Adults)
Placebo (Adolescents)

Trial Design

1Treatment groups
Experimental Treatment
Group I: BromocriptineExperimental Treatment1 Intervention
This is an open-label study, so there is no comparator group. As such there is only one arm. Subjects will receive bromocriptine at a starting dose of 2.5mg daily which will be increased, if tolerated, to 5mg daily after one week. Bromocriptine will be continued for a total of 6 weeks. Laboratory investigations, telephonic interviews, and face to face visits with subjects will be conducted before, during, and after the time period that bromocriptine will be used as detailed in the study design section.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bromocriptine
FDA approved

Find a Location

Who is running the clinical trial?

VA Pittsburgh Healthcare SystemLead Sponsor
33 Previous Clinical Trials
12,048 Total Patients Enrolled
1 Trials studying Schizophrenia
57 Patients Enrolled for Schizophrenia
Stanford UniversityOTHER
2,448 Previous Clinical Trials
17,492,379 Total Patients Enrolled
7 Trials studying Schizophrenia
320 Patients Enrolled for Schizophrenia
Ronald Codario, M.D.Principal InvestigatorVA Pittsburgh Healthcare System

Media Library

Bromocriptine Clinical Trial Eligibility Overview. Trial Name: NCT03575000 — Phase 4
Schizophrenia Research Study Groups: Bromocriptine
Schizophrenia Clinical Trial 2023: Bromocriptine Highlights & Side Effects. Trial Name: NCT03575000 — Phase 4
Bromocriptine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03575000 — Phase 4
~10 spots leftby Jul 2025
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