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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%
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HOMA-IR
Secondary outcome measures
75g Oral Glucose Tolerance Test
Abnormal Involuntary Movement Scale (AIMS)
Brief Psychiatric Rating Scale (BPRS)
+8 moreSide effects data
From 2019 Phase 2 trial • 108 Patients • NCT0254432131%
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
32 Previous Clinical Trials
11,389 Total Patients Enrolled
1 Trials studying Schizophrenia
57 Patients Enrolled for Schizophrenia
Stanford UniversityOTHER
2,387 Previous Clinical Trials
17,334,030 Total Patients Enrolled
7 Trials studying Schizophrenia
320 Patients Enrolled for Schizophrenia
Ronald Codario, M.D.Principal InvestigatorVA Pittsburgh Healthcare System
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any CYP3A4 inhibitor medications.I am not currently taking, nor have I taken any dopamine agonist medications in the last 3 months.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.I have been diagnosed with diabetes.I am not pregnant or breastfeeding and use reliable birth control or am surgically sterile.I am not allergic to and do not take any ergot alkaloids.You have a history of being violent.Your ECG heart test should show a QTc measurement of less than 500 milliseconds.Your PANSS score is higher than 90, which means you are moderately ill.You must have a negative drug test when you are screened and at the start of the study.You have not consistently taken your medication as prescribed in the last 3 months.Your heart's electrical activity (measured by ECG) takes too long to reset.I haven't taken any systemic corticosteroids in the last 3 months and don't plan to during the study.I've been on a stable dose of a second generation antipsychotic for 3 months.Your PANSS score is less than or equal to 90, which means you are considered moderately ill.I have a liver or kidney disease.I am between 18 and 65 years old and have been diagnosed with schizophrenia.I haven't taken any diabetes medication in the last 4 months.You have a body mass index (BMI) of 30 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Bromocriptine
Awards:
This trial has 5 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
- 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any opportunity for individuals to join this research endeavor?
"This clinical trial has reached its recruitment limit and is no longer enrolling patients. The original post date was March 1st, 2023 with the most recent update being on October 11th 2022. There are currently 462 trials for glucose intolerance as well as 6 trials utilizing Bromocriptine that are actively recruiting participants."
Answered by AI
Are there any recorded precedents of clinical trials utilizing Bromocriptine?
"Currently, six clinical trials involving bromocriptine are running. One has advanced to Phase 3 and eight different sites have been selected for the testing of this medication. Montreal, Quebec is at the epicenter of these studies."
Answered by AI
How many participants have registered for the experiment?
"At this moment, no further individuals are being sought for the trial. The information was initially published on March 1st 2023 and edited most recently on October 11th 2022. For those looking to join other clinical trials related to glucose intolerance, there are currently 462 such studies that are enrolling participants while 6 of them focus specifically on bromocriptine."
Answered by AI
What conditions is Bromocriptine most often recommended to treat?
"Bromocriptine is the primary therapy for hyperprolactinemia and can also be beneficial to patients with acromegaly, neuroleptic malignant syndrome (nms), and Parkinson's disease (PD)."
Answered by AI
Does the Food and Drug Administration recognize Bromocriptine as safe for public use?
"Assessing Bromocriptine's safety on a 1 to 3 scale, our experts at Power gave it a score of 3 due to the Phase 4 designation - indicating FDA approval."
Answered by AI
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