Aripiprazole and Prolactin Study- Version 1

• Research type

  Research Study

• Full title

  A pilot study of Aripiprazole treatment for antipsychotic induced hyperprolactinaemia in young patients with severe mental illness and learning disabilities.

• IRAS ID

  17861

• Contact name

  Guy Goodwin

• Sponsor organisation

  University of Oxford

• Eudract number

  2009-011228-73

• ISRCTN Number

  n/a

• Research summary

  Antipsychotic medicines are commonly used in young people with severe mental illness or learning disabilities. Like all medicines, antipsychotics have side effects. One is an increase in the hormone prolactin. A raised prolactin (Hyperprolactinaemia) decreases sex hormones secretion, leading to the equivalent of a premature menopause, which, like the normal menopause, increases the risk of osteoporosis and fractures. In the young, a high prolactin has even more severe consequences as it prevents the achievement of normal bone mass, thus predisposing patients to osteoporosis and fractures at an earlier age. Reducing prolactin by changing antipsychotic or adding any of the routine treatments for Hyperprolactinaemia can worsen the mental state. Addition of Aripiprazole, a novel antipsychotic, has been shown safely to normalize prolactin in mature schizophrenic patients with Hyperprolactinaemia due to other antipsychotics. We wish to confirm these findings in young people with severe mental illness and learning disabilities, as they are likely to enjoy greater benefits. We chose Aripiprazole as it also has a good safety record, with few side effects. We thus propose a 3 year study of Aripiprazole in 35 young people with Hyperprolactinaemia due to other antipsychotics. We will start with a very low dose and increase it by equally small steps until prolactin normalization. We will monitor response and check for side effects with blood tests and clinical measurements. We expect the effective dose to be well below the maximum safe dose and the drug to be well tolerated. The study will be conducted by the Dept. of Psychiatry at the University of Oxford, in collaboration with the Oxfordshire and Buckinghamshire Mental Health NHS Trust and the Ridgeway Partnership NHS Trust.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  10/H0604/5

• Date of REC Opinion

  9 Feb 2010

• REC opinion

  Further Information Favourable Opinion