Aripiprazole and Prolactin Study (APS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Oxford.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01085383
First received: March 10, 2010
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

Antipsychotic medicines are used routinely in young people with severe mental illness or learning disability, prescription rates increasing up to six fold in a decade. 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. Antipsychotic side effects in youth are well documented. Hyperprolactinemia inhibits normal pubertal and skeletal development. 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 young people (age 16-25)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.


Condition Intervention Phase
Hyperprolactinemia
Drug: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aripiprazole Treatment for Antipsychotic Induced Hyperprolactinaemia in Patients With Severe Mental Illness and Learning Disabilities

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Normalization or reduction in prolactin sufficient to restore gonadal function [ Time Frame: Monthly and then 6 monthly intervals over 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Normalization or improvement in bone mineral density [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 35
Study Start Date: April 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Aripiprazole
    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 Name: Abilify
  Eligibility

Ages Eligible for Study:   16 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants willing and able to give informed consent for participation in the study.
  • Males or Females, aged 16-25 years.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085383

Contacts
Contact: Valeria Frighi, MD -44-1865-223779 valeria.frighi@psych.ox.ac.uk
Contact: Guy M Goodwin, PhD -44-1865-226451 guy.goodwin@psych.ox.ac.uk

Locations
United Kingdom
University Dept. of Psychiatry Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7JX
Contact: Valeria Frighi, MD    00441865223779    valeria.frighi@psych.ox.ac.uk   
Principal Investigator: Guy G Goodwin, DPhil         
Sub-Investigator: Valeria Frighi, MD         
Sub-Investigator: Anthony C James, MRCPsych         
Sponsors and Collaborators
University of Oxford
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Guy M Goodwin, PhD University of Oxford
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01085383     History of Changes
Other Study ID Numbers: OCTUMI-03, 2009-011228-73
Study First Received: March 10, 2010
Last Updated: July 11, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
Antipsychotic
hyperprolactinemia
hypogonadism
aripiprazole

Additional relevant MeSH terms:
Learning Disorders
Hyperprolactinemia
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders
Antipsychotic Agents
Aripiprazole
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 10, 2014