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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

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

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 weeks3 visits

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)

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

headache

fatigue

severe hypoglycemia

100%

80%

60%

40%

20%

Study treatment Arm

Bromocriptine QR (Adolescents)

Bromocriptine QR (Adults)

Placebo (Adults)

Placebo (Adolescents)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

0 / 7Eligibility criteria met