HyperprolactinemiaPhase 4APSNCT01085383
Aripiprazole and Prolactin Study
A Phase 4 study testing Aripiprazole in people with Hyperprolactinemia, run by University of Oxford at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Hyperprolactinemia
- What is being tested?
- Aripiprazole
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2010to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Dept. of Psychiatry
Oxford, Oxfordshire, OX3 7JX
About this study
Official title: Aripiprazole Treatment for Antipsychotic Induced Hyperprolactinaemia in Patients With Severe Mental Illness and Learning Disabilities
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.
- Conditions
- Hyperprolactinemia
- Being tested
- Aripiprazole
- Keywords
- Antipsychotic, hyperprolactinemia, hypogonadism, aripiprazole
- Medical subject headings
- Hyperprolactinemia, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Monthly and then 6 monthly intervals over 2 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperprolactinemiaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Guy M Goodwin, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085383
- Sponsor's protocol ID
- OCTUMI-03
- Other IDs
- 2009-011228-73, 2009
- Acronym
- APS
- Status last verified
- May 2015
- First submitted
- 10 Mar 2010
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aripiprazole Treatment for Antipsychotic Induced Hyperprolactinaemia in Patients With Severe Mental Illness and Learning Disabilities
- ClinicalTrials.gov ID
- NCT01085383
- Acronym / sponsor ID
- APS / OCTUMI-03
- Conditions
- Hyperprolactinemia
- Keywords
- Antipsychotic, hyperprolactinemia, hypogonadism, aripiprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Apr 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AripiprazoleAlso: AbilifyAripiprazole 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 | Drug | – |
Primary outcome
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.
1 secondary outcome
Normalization or improvement in bone mineral density
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
Related trials for Hyperprolactinemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy M Goodwin, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole in people with Hyperprolactinemia, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalization or reduction in prolactin sufficient to restore gonadal function (time frame: Monthly and then 6 monthly intervals over 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.