Aripiprazole and Prolactin Study (APS)
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|ClinicalTrials.gov Identifier: NCT01085383|
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : May 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Hyperprolactinemia||Drug: Aripiprazole||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aripiprazole Treatment for Antipsychotic Induced Hyperprolactinaemia in Patients With Severe Mental Illness and Learning Disabilities|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
- Drug: Aripiprazole
Aripiprazole 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 reachedOther Name: Abilify
- Normalization or reduction in prolactin sufficient to restore gonadal function [ Time Frame: Monthly and then 6 monthly intervals over 2 years ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085383
|University Dept. of Psychiatry|
|Oxford, Oxfordshire, United Kingdom, OX3 7JX|
|Principal Investigator:||Guy M Goodwin, PhD||University of Oxford|