Could a Parkinson's drug fix antipsychotic side effects?
NCT ID NCT03575000
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This small pilot study tests whether bromocriptine, a drug used for Parkinson's, can safely improve blood sugar problems in people with schizophrenia who have prediabetes from antipsychotic medications. Fifteen adults will take bromocriptine for 6 weeks, with researchers monitoring safety, blood sugar, and psychiatric symptoms. The goal is to see if it's worth studying further as a way to prevent type 2 diabetes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bromocriptine (a dopamine agonist pill)
- What this could lead to
- If it works, this could point toward a safe, cheap way to prevent or delay type 2 diabetes in people with schizophrenia who take antipsychotics.
- What could go wrong
- This is a very small, early pilot study with only 15 people and no placebo group. It focuses on safety, not proof of effectiveness, so results may not lead to a treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult males and females, 18-65 years of age, diagnosed with schizophrenia 2. 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 (e.g., oral contraceptives, birth control diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, intrauterine devices, partner with vasectomy, or abstinence) until the study is complete. 3. Be treated with FDA-approved second generation antipsychotic medication for at least 3 months, with no change in dose in the 1 month prior to enrollment. 4. Either fasting glucose of 100 to 125 mg/dL inclusive and/or an A1C in the range between 5.7-6.4% 5. Body mass index at least 30 kg/m2 at screening visit. 6. Subject must be willing to provide contact information for a close family member or friend that will contact the study team if the participant exhibits signs of psychological deterioration 7. Subject's primary mental health provider concurs that study enrollment is acceptable Exclusion Criteria: 1. History of documented APD non-adherence in prior 3 months. 2. Historical or current diagnosis of diabetes mellitus (type 1, type 2, or other) 3. Pregnant or breast feeding. Women of child-bearing potential must be surgically-sterile or using reliable methods of birth control. 4. May not have used oral or parenteral systemic corticosteroids within 3 months prior to study enrollment or have expected use during the course of the study. The use of either inhaled or topical corticosteroids are not exclusion criteria. 5. May not be taking any antidiabetic/antihyperglycemic medications (e.g., metformin, sulfonylureas, thiazolidinediones, insulin, DPP-IV inhibitors, SGLT-2 inhibitors, etc.) currently or within 4 months prior to study enrollment. 6. May not be taking any of the following cytochrome P450 3A4 (CYP3A4) inhibitors: protease inhibitors (atazanavir, boceprevir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, telaprevir); certain antibiotics/antifungals (clarithromycin, erythromycin, telithromycin, chloramphenicol, ciprofloxacin, fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole); nefazodone; aprepitant; imatinib; certain calcium channel blockers (diltiazem, verapamil); Valerian; or grapefruit/grapefruit juice. 7. May not be taking or have sensitivity to any dopamine agonist medications (e.g., bromocriptine, cabergoline, pramipexole,ropinirole, rotigotine, etc.) currently or within 3 months prior to study enrollment. 8. May not be taking or have any sensitivity to any other ergot alkaloids (e.g., dihydroergotamine, ergotamine) 9. PANSS score \>90, which is equivalent to "moderately ill" 10. Any current hepatic or renal disease 11. Any documented history of violent behavior 12. Diagnosis of Alcohol use disorder or substance use disorder in the past 12 months unless meeting remission criteria as defined by MINI.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
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