The primary objective of this study is to test the hypothesis that discontinuation of antipsychotics does not lead to deterioration in functioning as measured by the ABC.
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be the proportion of people developing marked
behavioral symptoms calling for prescription of (higher doses of)
antipsychotics and thus leading to study withdrawal in both treatment groups.
Secondary outcome
Weight, middle circumference, BMI, fasting glucose, fasting triglyceride, total
cholesterol, HDL-and LDL-cholesterol, prolactin, CTX, P1NP, the Clinical Global
Impression (CGI), and the Visual Analogue Scale (VAS). Extrapyramidal symptoms
(AIMS), autonomic dysfunction (SCOPA-AUT).
Background summary
A substantial proportion of individuals with mental retardation chronically
utilizes antipsychotic medication. This may only be partially explained by the
presence of psychiatric disorders. Often, antipsychotics are being prescribed
without a clear indication, for ameliorating behavioral symptoms, such as
aggression, and irritable and provocative behavior.
Long time use of antipsychotics may have substantial health risks, including
weight gain, glucose dysregulation, hyperlipidemia, and hyperprolactinemia.
Another side-effect associated with the long term use of antipsychotics is
osteoporosis, resulting from hyperprolactinemia-induced hypogonadism. Other
significant side-effects may also occur in association with the use of
antipsychotics, such as emotional and cognitive blunting, and extrapiramidal
symptoms like dystonia, dyskinesia, and akathisia.
Study objective
The primary objective of this study is to test the hypothesis that
discontinuation of antipsychotics does not lead to deterioration in functioning
as measured by the ABC.
Study design
A randomized controlled discontinuation study design will be used.
Intervention
A random number table will allocate 100 subjects in a 1:1 ratio to either a
group that will be gradually tapered off antipsychotic treatment over 14 weeks
or a group that will be tapered off over 28 weeks
Study burden and risks
Participants will undergo two venapunction and three physical examinations
including measurements of weight and middle circumference, pulse and blood
pressure, and examination for extrapyramidal symptoms. As a result of
antipsychotics discontinuation there may be a risk of (temporarily) worsening
of behavior.
Hanzeplein 1
9713 GZ Groningen
NL
Hanzeplein 1
9713 GZ Groningen
NL
Listed location countries
Age
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.
Exclusion criteria
a) a history of schizophrenia, a bipolar disorder, or affective psychosis according to DSM IV criteria and b) a history of unsuccessful withdrawal of antipsychotics in the past 6 months.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-005451-42-NL |
| CCMO | NL24349.042.08 |
| OMON | NL-OMON22173 |