Year:
2011-2014
Region / city:
Oxford, United Kingdom
Topic:
Aripiprazole treatment, antipsychotic induced hyperprolactinaemia
Document type:
Clinical trial report
Organization / institution:
University of Oxford
Author:
Guy Goodwin, Valeria Frighi, Matthew Stephenson, Alireza Morovat, Anthony James
Target audience:
Medical professionals, researchers, healthcare providers
Period of validity:
2011-2014
Approval date:
Not specified
Date of changes:
Not specified
Study initiation date:
27/4/2011
Date of termination:
31/12/2014
Date of current report:
4/8/2016
Principal Investigator:
Guy Goodwin
Clinical Coordinator and contact person:
Dr. Valeria Frighi
Study centers:
University of Oxford, Oxford Health NHS Foundation Trust, Oxfordshire Learning Disability NHS Trust
Diagnosis:
Severe mental illness and/or learning disability with antipsychotic induced hyperprolactinaemia
Test drug:
Aripiprazole (Abilify)
Study drug dose:
2.5-30 mg daily planned, 1.5-10 mg used
Follow-up duration:
Median 6.1 months
Evaluation criteria:
Efficacy (prolactin reduction, menses normalization, testosterone normalization), Safety (metabolic parameters, psychiatric/neurological symptoms)
Safety results:
No unexpected adverse reactions, known adverse reactions occurred in 2 patients
Efficacy results:
Significant reduction of prolactin in patients on risperidone or paliperidone, restoration of normal gonadal function
Statistical methods:
Mann-Whitney U test, paired t-tests
Context:
Clinical trial report on the efficacy and safety of adjunctive aripiprazole treatment for hyperprolactinaemia in patients with severe mental illness and learning disabilities
