Aripiprazole and Prolactin Study (APS)
This study is currently recruiting participants.
Verified July 2012 by University of Oxford
Sponsor:
University of Oxford
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
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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
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:
|
Hyperprolactinemia Learning Disorders 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 May 16, 2013