Aripiprazole and Prolactin Study

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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