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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Cabergoline (Dopamine Agonist)

    Drug

    This intervention will use cabergoline for antipsychotic induced hyperprolactinemia.

  • Placebo

    Drug

    Placebo + standard care

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: InterventionActive comparator 1 intervention

Trial outcomes

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).

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zealand University Hospital

Lead sponsor

Region Zealand

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: