E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
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 |
To critically investigate whether there is an indication for long term use of antipsychotic agents prescribed for behavioral symptoms in patients with mental retardation, or if this medication may be safely discontinued, without deterioration of behavioral symptoms |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the degree of reversibility upon discontinuation of the metabolic side-effects associated with the long term use of antipsychotics. What happens with weight, sexual side-effects, glucose metabolism, lipid metabolism, and bone metabolism when patients stop taking antipsychotic agents?
The identification of factors which may determine the outcome of discontinuation, including (ir)reversibility of side-effects. These possible predictors include sex, age, the cause of a patient’s mental retardation, duration of antipsychotics’ use, type of antipsychotic agent, genetic polymorphisms, level of cognitive functioning, possible presence of comorbid disorders, type of living situation (family home, group home, community home, (semi) residential setting) and social climate, and level of daily activities. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Institutionalized persons with mental retardation aged between 15-65 year currently receiving antipsychotics for behavioral symptoms for 12 months or longer are eligible. Behavioral symptoms will be defined as challenging, disruptive, or aggressive behavior to self, others, or materials, either physically or verbally, including sexually aggressive behavior. |
|
E.4 | Principal exclusion criteria |
a) a history of schizophrenia or a bipolair disorder according to DSM IV criteria
b) a history of unsuccessful withdrawal of antipsychotics in the past 12 months. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The aberrant behavior checklist (ABC), the Clinical Global Impression (CGI), and the Visual Analogue Scale (VAS). |
|
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 | Yes |
E.6.4 | Safety | Yes |
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 | Yes |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 5 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |