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Hyperprolactinemia | Aripiprazole and Prolactin Study

Hyperprolactinemia research study

What is the primary objective of this study?

Antipsychotic medicines are used routinely in people with severe mental illness or learning disability. Antipsychotics often induce hyperprolactinemia (high prolactin level) and in almost all women, and some men, this causes hypogonadism (impaired ovarian or testicular function)often with osteoporosis, partly explaining psychiatric patients' high fracture risk. Reducing prolactin by changing antipsychotic or adding a dopamine agonist often worsens psychosis. Adding aripiprazole to current antipsychotic normalizes prolactin in adult schizophrenic patients, without serious side effects. We thus plan a study of add-on aripiprazole in people with antipsychotic induced hyperprolactinemia. Our main hypothesis is that aripiprazole will normalize or reduce prolactin sufficiently to restore normal ovarian and testicular function. Our secondary hypothesis is that restoration of normal ovarian and testicular function will improve bone mineral density in patients in whom this was reduced at the time of entry into the study.

Who is eligible to participate?

Inclusion Criteria: - Participants willing and able to give informed consent for participation in the study. - Males or Females, aged 16-50 years (women), 16-60 (men). - Diagnosed with antipsychotic induced hyperprolactinaemia of sufficient severity to induce secondary hypogonadism. - Stable dose of current regular antipsychotic medication for at least three months prior to study entry. - Female participants of child bearing potential willing to ensure that they or their partner use effective contraception during the study and for 1 month thereafter - Able (in the Investigators opinion) and willing to comply with all study requirements. - Willing to allow his or her General Practitioner and consultant to be notified of participation in the study. Exclusion Criteria: - Pregnancy or breastfeeding - Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. - Plans to donate blood during the study - Participants who have participated in another research study involving an investigational product in the past 8 weeks - Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. - Plans to donate blood during the study - Participants who have participated in another research study involving an investigational product in the past 8 weeks

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hyperprolactinemia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AripiprazoleAripiprazole will be started at 5 mg daily and increased in a treat-to-target fashion by 5 mg steps until the primary outcome or the maximum tolerated or permitted dose of 30 mg is reached

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Completed

Start Date: April 2010

Completed Date: December 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Normalization or reduction in prolactin sufficient to restore gonadal function

Secondary Outcome: Normalization or improvement in bone mineral density

Study sponsors, principal investigator, and references

Principal Investigator: Guy M Goodwin, PhD

Lead Sponsor: University of Oxford

Collaborator: National Institute for Health Research, United Kingdom

More information:https://clinicaltrials.gov/show/NCT01085383

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