A pilot study of Aripiprazole treatment for antipsychotic induced hyperprolactinaemia in young patients with severe mental illness and learning disabilities. - Aripiprazole and Prolactin Study- Version 1

• Conditions: Antipsychotic induced hyperprolactinaemia; MedDRA version: 12Level: LLTClassification code 10020737Term: Hyperprolactinaemia

• Registration Number: EUCTR2009-011228-73-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-15
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria

1) Patients with severe mental illness or learning disability aged 16-25 with antipsychotic induced hyperprolactinaemia causing impaired ovarian or testicular function This will be defined by a raised plasma prolactin level accompanied by amenorrhoea or oligomenorrhoea in women and testosterone levels below the lower limit of the normal range in men (i.e. < 8.4 nmol/l).

2) Stable dose of current regular antipsychotic medication for at least three months prior to study entry.

3)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

4) Able (in the Investigators opinion) and willing to comply with all study requirements.

5) Capable of giving informed consent

6)Willing to allow his or her General Practitioner and consultant to be notified of participation in the study.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Previous adverse effects to treatment with aripiprazole
2) Adverse mental state not allowing the use of aripiprazole. Patients in this group could be included at a later stage should the mental state improve sufficiently to consider inclusion in the study to be safe.
3)Pregnancy or breast feeding
4)Severe physical illness
5)Use of steroid hormones
6) Plans to donate blood during the study
7) Participation in another research study involving an investigational product in the past eight weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Can addition of aripiprazole to current antipsychotic normalize or reduce prolactin sufficiently to restore normal function of the ovaries and the testes? <br><br><br>;Secondary Objective: Can aripiprazole improve bone strength in young people in whom this was low because of the raised prolactin?;Primary end point(s): Normalization of prolactin or decrease sufficient to restore normalization of ovarian and testicular function as shown by normalization of menses in women and of testosterone levels in men