E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Antipsychotic induced hyperprolactinaemia |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020737 |
E.1.2 | Term | Hyperprolactinaemia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Can addition of aripiprazole to current antipsychotic normalize or reduce prolactin sufficiently to restore normal function of the ovaries and the testes?
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E.2.2 | Secondary objectives of the trial |
Can aripiprazole improve bone strength in young people in whom this was low because of the raised prolactin? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial will be the last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |