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Starting soon Phase 4

Carbergoline for Antipsychotic Induced Hyperprolactinemia.

NCT07386080 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 4
Started
2026-05-01
Last updated
2026-02-04

Condition(s) studied

Scizophrenia

Investigational drug(s) / intervention(s)

Cabergoline (Dopamine Agonist) →Placebo

Cabergoline (Dopamine Agonist): This intervention will use cabergoline for antipsychotic induced hyperprolactinemia.

Placebo: Placebo + standard care

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Total score on the PANSS (Positive and Negative Syndrome Scale) — At end of intervention, i.e. 12 weeks from baseline.
    The primary outcome is the total score of the PANSS in absolute numbers at the end of intervention (12 weeks) comparing the placebo group with the intervention group (cabergoline).

Trial sites (1)

FacilityCityRegionStatus
Zealand University Hospital Køge Region Sjælland
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07386080 on ClinicalTrials.gov ↗ ← All trials in Denmark