Carbergoline for Antipsychotic Induced Hyperprolactinemia.
ConditionScizophrenia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorZealand University Hospital
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
patients that has previously responded unfavorably to treatment with a dopamine receptor agonist.
The use of recreational drugs that may give hyperprolactinemia.
Trial design
Treatments tested in this trial
- Cabergoline (Dopamine Agonist)
- Placebo
Treatment groups
146 Participants
are divided into 2 treatment groupsSponsors and collaborators
Zealand University Hospital
Lead sponsor
Region Zealand
Collaborator
Source ClinicalTrials.gov