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Completed

NCT Number: NCT01085383

Aripiprazole and Prolactin Study

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.

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Key information

Conditions

Hyperprolactinemia Brain Diseases Central Nervous System Diseases Endocrine System Diseases Gonadal Disorders Hyperpituitarism Hypogonadism Hypothalamic Diseases Nervous System Diseases Pituitary Diseases

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Dept. of Psychiatry

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aripiprazole

Drug

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 reached

Other names: Abilify

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

Aripiprazole Treatment for Antipsychotic Induced Hyperprolactinaemia in Patients With Severe Mental Illness and Learning Disabilities

Acronym: APS

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2010
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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