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

niversity of Oxford0 个研究点开始时间: 2010年3月15日最近更新: 2015年8月4日

适应症

试验速览

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•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

•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

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