NCT07386080

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for phase_4

Timeline
34mo left

Started May 2026

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
May 2026May 2029

First Submitted

Initial submission to the registry

January 27, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 27, 2026

Last Update Submit

January 27, 2026

Conditions

Scizophrenia

Keywords

prolactincabergoline

Outcome Measures

Primary Outcomes (1)

  • Total score on the PANSS (Positive and Negative Syndrome Scale)

    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).

    At end of intervention, i.e. 12 weeks from baseline.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo tablets + standard care

Drug: Placebo

Intervention

ACTIVE COMPARATOR

Cabergoline tablets + standard care

Drug: Cabergoline (Dopamine Agonist)

Interventions

Cabergoline (Dopamine Agonist)DRUG

This intervention will use cabergoline for antipsychotic induced hyperprolactinemia.

Intervention
PlaceboDRUG

Placebo + standard care

Placebo

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThe study only accepts participants with in which biological sex and gender identity is aligned. This is partly due to the studies ability to identify side effects of high prolactin levels, i.e. lack of periods, breast discharge and partly due to biochemical assessment of gonadotropines and prolactin which is specific to the biological sex.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • patients that has previously responded unfavorably to treatment with a dopamine receptor agonist.
  • The use of recreational drugs that may give hyperprolactinemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

Location

Related Publications (3)

  • Kuroki T, Watanabe Y, Yamai S, Obara Y, Takizawa K. [Detection of Neisseria gonorrhoeae antigens by an enzyme immunoassay (Gonozyme)]. Kansenshogaku Zasshi. 1985 Dec;59(12):1236-40. doi: 10.11150/kansenshogakuzasshi1970.59.1236. No abstract available. Japanese.

    PMID: 3938800BACKGROUND

  • Gonzalez-Rodriguez A, Labad J, Seeman MV. Antipsychotic-induced Hyperprolactinemia in aging populations: Prevalence, implications, prevention and management. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Jul 13;101:109941. doi: 10.1016/j.pnpbp.2020.109941. Epub 2020 Mar 31.

    PMID: 32243999BACKGROUND

  • Lang K, Meyers JL, Korn JR, Lee S, Sikirica M, Crivera C, Dirani R, Menzin J. Medication adherence and hospitalization among patients with schizophrenia treated with antipsychotics. Psychiatr Serv. 2010 Dec;61(12):1239-47. doi: 10.1176/ps.2010.61.12.1239.

    PMID: 21123409BACKGROUND

MeSH Terms

Interventions

CabergolineDopamine Agonists

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingDopamine AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Officials

  • Jesper Krogh

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesper Krogh, MD, PhD.

CONTACT

+45 25535485jekrog@regionsjaelland.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 4, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2029

Last Updated

February 4, 2026

Record last verified: 2026-01

Locations

DK(1)