Hyperprolactinemia Clinical Trial
Official title:
Aripiprazole Treatment for Antipsychotic Induced Hyperprolactinaemia in Patients With Severe Mental Illness and Learning Disabilities
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.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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