Aripiprazole and Prolactin Study (APS)
Primary Purpose
Hyperprolactinemia
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Hyperprolactinemia focused on measuring Antipsychotic, hyperprolactinemia, hypogonadism, aripiprazole
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
Sites / Locations
- University Dept. of Psychiatry
Outcomes
Primary Outcome Measures
Normalization or reduction in prolactin sufficient to restore gonadal function
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
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
Full Information
NCT ID
NCT01085383
First Posted
March 10, 2010
Last Updated
May 27, 2015
Sponsor
University of Oxford
Collaborators
National Institute for Health Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT01085383
Brief Title
Aripiprazole and Prolactin Study
Acronym
APS
Official Title
Aripiprazole Treatment for Antipsychotic Induced Hyperprolactinaemia in Patients With Severe Mental Illness and Learning Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
National Institute for Health Research, United Kingdom
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperprolactinemia
Keywords
Antipsychotic, hyperprolactinemia, hypogonadism, aripiprazole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
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
Primary Outcome Measure Information:
Title
Normalization or reduction in prolactin sufficient to restore gonadal function
Description
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.
Time Frame
Monthly and then 6 monthly intervals over 2 years
Secondary Outcome Measure Information:
Title
Normalization or improvement in bone mineral density
Description
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
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy M Goodwin, PhD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Dept. of Psychiatry
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7JX
Country
United Kingdom
12. IPD Sharing Statement
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Aripiprazole and Prolactin Study
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