Brief Title
Aripiprazole and Prolactin Study
Official Title
Aripiprazole Treatment for Antipsychotic Induced Hyperprolactinaemia in Patients With Severe Mental Illness and Learning Disabilities
Brief Summary
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Normalization or reduction in prolactin sufficient to restore gonadal function
Secondary Outcome
Normalization or improvement in bone mineral density
Condition
Hyperprolactinemia
Intervention
Aripiprazole
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
15
Start Date
April 2010
Completion Date
December 2014
Primary Completion Date
December 2014
Eligibility Criteria
Inclusion Criteria:
- Participants willing and able to give informed consent for participation in the study.
- Males or Females, aged 16-50 years (women), 16-60 (men).
- Diagnosed with antipsychotic induced hyperprolactinaemia of sufficient severity to
induce secondary hypogonadism.
- Stable dose of current regular antipsychotic medication for at least three months
prior to study entry.
- Female participants of child bearing potential willing to ensure that they or their
partner use effective contraception during the study and for 1 month thereafter
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant to be notified of
participation in the study.
Exclusion Criteria:
- Pregnancy or breastfeeding
- Any significant disease or disorder which, in the opinion of the Investigator, may
either put the participants at risk because of participation in the study, or may
influence the result of the study, or the participant's ability to participate in the
study.
- Plans to donate blood during the study
- Participants who have participated in another research study involving an
investigational product in the past 8 weeks
- Any significant disease or disorder which, in the opinion of the Investigator, may
either put the participants at risk because of participation in the study, or may
influence the result of the study, or the participant's ability to participate in the
study.
- Plans to donate blood during the study
- Participants who have participated in another research study involving an
investigational product in the past 8 weeks
Gender
All
Ages
16 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Guy M Goodwin, PhD, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT01085383
Organization ID
OCTUMI-03
Secondary IDs
2009-011228-73
Responsible Party
Sponsor
Study Sponsor
University of Oxford
Collaborators
National Institute for Health Research, United Kingdom
Study Sponsor
Guy M Goodwin, PhD, Principal Investigator, University of Oxford
Verification Date
May 2015