Bromocriptine for Schizophrenia and Diabetes-Related Issues

Overseen By Mary McShea, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: VA Pittsburgh Healthcare System

Must be taking: Second generation antipsychotics

Must not be taking: Corticosteroids, Antidiabetics, CYP3A4 inhibitors, Dopamine agonists

Disqualifiers: Diabetes, Pregnancy, Substance use, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effects of bromocriptine on both schizophrenia and diabetes-related issues. The goal is to determine if bromocriptine can safely improve blood sugar control in individuals taking antipsychotic drugs, which can sometimes affect blood sugar levels. Participants should have schizophrenia, be on second-generation antipsychotic medication for at least three months, and have elevated blood sugar levels that are not yet diabetic. The trial aims to demonstrate that bromocriptine is safe and could potentially prevent or delay type 2 diabetes in these patients. As a Phase 4 trial, bromocriptine has already received FDA approval and proven effective, and this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot be on medications that interact with bromocriptine, such as some antibiotics, antifungals, or dopamine agonists, and you must not be taking any antidiabetic medications or corticosteroids. It's best to discuss your current medications with the study team to see if they are allowed.

What is the safety track record for bromocriptine?

Research has shown that bromocriptine is generally safe for people. In past studies, participants taking bromocriptine experienced serious side effects at about the same rate as those taking a placebo, a harmless pill. Specifically, about 8.6% of those on bromocriptine had serious side effects, compared to 9.6% in the placebo group, indicating that bromocriptine is not riskier than a placebo.

The FDA has already approved bromocriptine to treat type 2 diabetes under the name Cycloset. In those studies, there was no higher risk of stroke compared to a placebo. However, bromocriptine has been linked to some side effects, such as lung tissue scarring and lower levels of growth hormone in certain cases.

Overall, while bromocriptine appears promising, participants should discuss potential risks with their healthcare providers before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Bromocriptine is unique because it targets both schizophrenia and diabetes-related issues, which is not typical for standard treatments. Unlike other schizophrenia medications that primarily focus on neurotransmitter modulation, bromocriptine works as a dopamine agonist, which can help address insulin resistance, a common problem for patients with diabetes. Researchers are excited about bromocriptine because it has the potential to simplify treatment regimens by addressing two significant health issues with one medication, improving overall patient outcomes and quality of life.

What evidence suggests that bromocriptine might be an effective treatment for schizophrenia-related metabolic issues?

Research has shown that bromocriptine can help manage type 2 diabetes and related metabolic issues. This medication activates certain parts of the brain, improving insulin use and blood sugar control. In this trial, participants will receive bromocriptine to evaluate its potential benefits for patients with schizophrenia who are taking antipsychotic drugs. Bromocriptine may help these patients respond better to insulin and manage blood sugar levels more effectively. Its approval for treating type 2 diabetes supports its potential effectiveness for related metabolic issues. Therefore, bromocriptine could be a promising option for addressing the metabolic side effects of antipsychotic medications. ^{2 6 7 8 9}

Who Is on the Research Team?

Ronald Codario, MD

Principal Investigator

VA Pittsburgh Healthcare System

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subject's primary mental health provider concurs that study enrollment is acceptable

I am not pregnant and agree to use birth control during the study.

My blood sugar or A1C levels are slightly elevated but not diabetic.

Exclusion Criteria

I am not currently taking, nor have I taken any dopamine agonist medications in the last 3 months.

I am not taking any CYP3A4 inhibitor medications.

You have a history of being violent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive bromocriptine as an adjunct to their current APD regimen, with doses titrated from 2.5mg to 5mg daily over 6 weeks

6 weeks

Weekly visits (in-person and telephonic)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of psychiatric symptoms and side effects

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bromocriptine

Trial Overview 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.

How Is the Trial Designed?

Group I: Bromocriptine Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

VA Pittsburgh Healthcare System

Lead Sponsor

Trials

36

Recruited

15,900+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03575000?term=bromocriptine&rank=8

Bromocriptine for Patients with Schizophrenia and ... The ultimate aim of the study team is to evaluate the efficacy of bromocriptine in treating the metabolic disturbances associated with APDs and the hypothesis ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK555948/

Bromocriptine - StatPearls - NCBI Bookshelf - NIH Bromocriptine, an ergot alkaloid derivative classified as a dopamine D2 agonist, is a medication used to manage type 2 diabetes, Parkinson disease, acromegaly, ...

3. withpower.com withpower.com/trial/phase-4-glucose-intolerance-3-2019-ebea3

Bromocriptine for Schizophrenia and Diabetes-Related ... The primary metabolic outcome measures will be change in IR as measured by the HOMA-IR and change in IGT measured by HbA1c. Secondary metabolic outcome measures ...

4. veroscience.com veroscience.com/news/cycloset-bromocriptine-mesylate-included-in-american-association-of-clinical-endocrinologists-comprehensive-diabetes-management-algorithm/

Cycloset (bromocriptine mesylate) Included in American ... Psychosis: May exacerbate psychotic disorders or reduce the effectiveness of drugs that treat psychosis. Use in patients with severe psychotic disorders is ...

5. pharmacytimes.com pharmacytimes.com/view/novel-treatment-for-the-management-of-type-2-diabetes-in-adults

Cycloset® (bromocriptine mesylate) Tablets: A Novel ... CYCLOSET may exacerbate psychotic disorders or reduce the effectiveness of drugs that treat psychosis. Use in patients with severe psychotic disorders is ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20332352/

Randomized clinical trial of quick-release bromocriptine ... Results: In the bromocriptine-QR group, 176 (8.6%) people reported SAEs compared with 98 (9.6%) in the placebo group (HR 1.02 [96% one-sided CI 1.27]). Fewer ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1924849/

A randomized, double-blind, placebo-controlled trial to assess ... This study will provide data that permits the estimation of serious adverse event incidence rate differences and ratios between Cycloset™ and placebo when these ...

8. rxlist.com rxlist.com/cycloset-drug.htm

Cycloset (Bromocriptine Mesylate Tablets): Side Effects, ... Based on the CYCLOSET clinical trials, there is no evidence of increased risk for stroke when CYCLOSET is used to treat type 2 diabetes. Neuroleptic-Like ...

9. go.drugbank.com go.drugbank.com/drugs/DB01200

Bromocriptine: Uses, Interactions, Mechanism of Action Bromocriptine has been associated with pulmonary fibrosis, and can also cause sustained suppression of somatotropin (growth hormone) secretion in some patients ...