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NCT03575000 · ClinicalTrials.gov registry record · Phase 4
Bromocriptine for Patients With Schizophrenia and Prediabetes
A Phase 4 study, sponsored by VA Pittsburgh Healthcare System.
- Not yet
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT03575000 is a Phase 4 study that has not yet begun recruiting, run by VA Pittsburgh Healthcare System. The registered enrollment target is 15 participants.
The verdict
NCT03575000, a Phase 4 study, has not yet begun recruiting, sponsored by VA Pittsburgh Healthcare System.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a multicenter open-label, pilot study to evaluate the safety and tolerability of bromocriptine, a dopamine D2/D3 receptor and serotonin 5-HT2C receptor agonist, as an adjunct to preexisting standard-of-care antipsychotic drug (APD) regimens in the management of APD-associated impaired glucose tolerance (IGT)/insulin resistance (IR). 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 is that bromocriptine will be a well-tolerated, safe, and inexpensive way to ameliorate these metabolic complications and prevent or delay the onset of type 2 diabetes (T2D). This study will be a small, short-duration pilot focusing on safety and tolerability. A total of 15 psychiatrically stable APD-treated adult outpatients, VA Pittsburgh , aged 18 to 65 years old, with a confirmed diagnosis of schizophrenia and comorbid IGT will be recruited and receive 6 weeks of bromocriptine (flexibly titrated, 2.5-5.0 mg PO daily). Key inclusion criteria are: 1) currently being treated with second generation APDs for 3 or more months with no change in dose in the 1 month prior to enrollment, 2) fasting glucose 100 to 125mg/dL and/or hemoglobin A1c (HbA1c) 5.7-6.4%. Key exclusions are: 1) prior APD nonadherence, 2) drug/alcohol abuse in the 3 months prior to screening, 3) a history of violent behavior/psychoses, 4) pregnancy, or 5) a diagnosis of diabetes. Subjects on other dopamine agonists or on medications that may interact with bromocriptine and those taking corticosteroids or other medications that may alter glucose levels will be excluded. The purposes of the study are to demonstrate safety/tolerability, demonstrate feasibility, provide proof of concept, and provide an open-label assessment of the metabolic and psychiatric effects of bromocriptine in patients with schizophrenia treated with APDs. The primary metabolic outcome measures will be change in IR as measured by the HOMA
Interventions
- DRUG Bromocriptine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2026-01-01 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03575000
The ClinicalTrials.gov registry entry for NCT03575000 describes a study currently listed as not yet recruiting, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Pittsburgh Healthcare System, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bromocriptine is the first listed.
NCT03575000 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03575000 about?
NCT03575000 is a clinical study titled "Bromocriptine for Patients With Schizophrenia and Prediabetes". This is a multicenter open-label, pilot study to evaluate the safety and tolerability of bromocriptine, a dopamine D2/D3 receptor and serotonin 5-HT2C receptor agonist, as an adjunct to preexisting standard-of-care antipsychotic drug (APD) regimens in the management of APD-associated impaired glucos...
What is the current status of trial NCT03575000?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2026-01-01. Estimated completion is 2026-07-31.
What interventions are being tested in trial NCT03575000?
The interventions under investigation include: Bromocriptine (DRUG).
Who is sponsoring clinical trial NCT03575000?
This trial is sponsored by VA Pittsburgh Healthcare System, which has 17 total clinical trials registered on ClinicalTrials.gov.
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