Carbergoline for Antipsychotic Induced Hyperprolactinemia. (NCT07386080) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Carbergoline for Antipsychotic Induced Hyperprolactinemia.
Denmark146 participantsStarted 2026-05-01
Plain-language summary
The goal of this clinical trial is to learn if cabergoline is safe to use in patients with antipsychotic-induced hyperprolactinemia in adults with scizophrenia. The main question it aims to answer :
Is the severity of positive and negative symptoms affected by the use of cabergoline?
Researchers will compare cabergolin to placebo to see if positive and negative symptoms are equel in both groups.
Participants will, in a blinded manor, take either placebo tablets or cabergoline for 12 weeks. The severity of positive and negative symptoms will be evaluated before and after the intervention in both groups.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* receiveing antipsychotic treatment for at least 3 months for a schizophrenia spectrum disorder
* Prolactin levels \> URL
* symptoms of hyperprolactinemia according to he UKU side effect scale (Udvalg for Klinisk Undersøgelser)
* no suicide ideation at time of recruitment (≤ 2 Columbia-Suicide Serverity Rating Scale)
Exclusion Criteria:
* patients that has previously responded unfavorably to treatment with a dopamine receptor agonist.
* The use of recreational drugs that may give hyperprolactinemia.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total score on the PANSS (Positive and Negative Syndrome Scale)
Timeframe: At end of intervention, i.e. 12 weeks from baseline.