Aripiprazole and Prolactin Study (APS)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Aripiprazole Treatment for Antipsychotic Induced Hyperprolactinaemia in Patients With Severe Mental Illness and Learning Disabilities|
- Normalization or reduction in prolactin sufficient to restore gonadal function [ Time Frame: Monthly and then 6 monthly intervals over 2 years ] [ Designated as safety issue: No ]Prolactin and sex hormones will be measured on addition of aripiprazole to current antipsychotic treatment. Aripiprazole will be started at 5 mg and uptitrated in a treat-to-target fashion by 5 mg at monthly intervals until prolactin has normalized or decreased sufficiently to restore menses in the women and a normal testosterone in the men. Maximum aripiprazole dose will be 30 mg.
- Normalization or improvement in bone mineral density [ Time Frame: 2 years ] [ Designated as safety issue: No ]Bone mineral density will be measured at baseline in patients aged 20 years or older with a presumed duration of hypogonadism of minimum one year. The measurement will be repeated in those with a low bone mineral density at baseline after two years aripiprazole treatment
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085383
|University Dept. of Psychiatry|
|Oxford, Oxfordshire, United Kingdom, OX3 7JX|
|Principal Investigator:||Guy M Goodwin, PhD||University of Oxford|