Aripiprazole and Prolactin Study

NCT01085383 | Completed Phase 4

• 2 other identifiers: OCTUMI-032009-011228-73
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperprolactinemia

Keywords

Antipsychotic; hyperprolactinemia; hypogonadism; aripiprazole

Outcome Measures

Primary Outcomes (1)

• 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.

  Monthly and then 6 monthly intervals over 2 years

Secondary Outcomes (1)

• Normalization or improvement in bone mineral density

  2 years

Interventions

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

Also known as: Abilify

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

University Dept. of Psychiatry

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

MeSH Terms

Conditions

Hyperprolactinemia; Hypogonadism

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Guy M Goodwin, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 11, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

GB (1)