Primary study objective Is the reduction of 1 to several antipsychotic antipsychotic associated with more relapse? Relapse is measured with the Brief Psychiatric Rating Scale (BPRS) and is defined as: - An absolute increase of> 2 on one of theā¦
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study objective
Is the reduction of 1 to several antipsychotic antipsychotic associated with
more relapse?
Relapse is measured with the Brief Psychiatric Rating Scale (BPRS) and is
defined as:
- An absolute increase of> 2 on one of the following BPRS items:
disorganization, hallucinatory behavior, suspiciousness, unusual thought
content, that specific items since the last visit, or
- An absolute increase of> 4 in the BPRS total score of the following items:
disorganization, hallucinatory behavior, suspiciousness, unusual thought
content since the last visit.
Secondary outcome
Secondary study objectives
1.Does reducing multiple antipsychotics to 1 antipsychotic affect symptoms of
schizophrenia measured by the BPRS
2. Does reducing multiple antipsychotics to 1 antipsychotic affect the number
and nature of adverse events measured with the UKU
3. Does reducing multiple antipsychotics to 1 antipsychotic affect metabolic
parameters.
4. Does reducing multiple antipsychotics to 1 antipsychotic affect symptoms of
dyskinesia and EPS respectively measured with the AIMS, BARS and the UPDRS.
5. Does reducing multiple antipsychotics to 1 antipsychotic affect the quality
of life measured with the SWN
6. Does reducing multiple antipsychotics to 1 antipsychotic affect the care
needs measured by the Honos
Background summary
Treatment with multiple classes of psychotics is common practice. There is
limited evidence that prescribing multiple antipsychotics in the acute phase
may be beneficial with regard to improvement in PANSS scores, however there is
no evidence for sustained treatment with multiple antipsychotics with regard to
outcome and side effects.
Study objective
Primary study objective
Is the reduction of 1 to several antipsychotic antipsychotic associated with
more relapse?
Relapse is measured with the Brief Psychiatric Rating Scale (BPRS) and is
defined as:
- An absolute increase of> 2 on one of the following BPRS items:
disorganization, hallucinatory behavior, suspiciousness, unusual thought
content, that specific items since the last visit, or
- An absolute increase of> 4 in the BPRS total score of the following items:
disorganization, hallucinatory behavior, suspiciousness, unusual thought
content since the last visit.
Secondary study objectives
1.Does reducing multiple antipsychotics to 1 antipsychotic affect symptoms of
schizophrenia measured by the BPRS
2. Does reducing multiple antipsychotics to 1 antipsychotic affect the number
and nature of adverse events measured with the UKU
3. Does reducing multiple antipsychotics to 1 antipsychotic affect metabolic
parameters.
4. Does reducing multiple antipsychotics to 1 antipsychotic affect symptoms of
dyskinesia and EPS respectively measured with the AIMS, BARS and the UPDRS.
5. Does reducing multiple antipsychotics to 1 antipsychotic affect the quality
of life measured with the SWN
6. Does reducing multiple antipsychotics to 1 antipsychotic affect the care
needs measured by the Honos
Study design
prospective open label randomised study
Intervention
It is an open label randomized study involving patients diagnosed with
schizophrenia. The randomization takes place 1: 1. There will be randomized to
2 options: 1. Patient has a combination of first and second generation and then
continues,
2: patient has a combination of first and second generation antipsychotics and
a. tapers and discontinues the first-generation antipsychotic, or
b. tapers and discontinues the second-generation antipsychotic.
Study burden and risks
There limited evidence for prescribing multiple antipsychotics. Multiple
antipsychotic drugs may give a higher risk of side effects such as dyskinesia,
metabolic syndrome and reduced subjective well-being. A reduction in the number
of prescribed antipsychotics per patient might render an improvement in these
side effects with a potentially longer lifespan. Though there is little
evidence for prescribing multiple antipsychotics, it is possible that the
reduction of different antipsychotics to one antipsychotic may provide an
increase of psychiatric symptoms associated with schizophrenia. When weighing
the risk of relapse with possible side effects and improvements in subjective
well-being, the risk appears acceptable after appropriate risk information in
the form of an informed consent.
Utrechtseweg 266
3800 DB Amersfoort
NL
Utrechtseweg 266
3800 DB Amersfoort
NL
Listed location countries
Age
Inclusion criteria
Patients diagnosed with schizophrenia. Diagnosis is determined by the MINI Plus (van Vliet and the Fair 2007)
Patients treated with both first-and half-generation antipsychotic
Age 18 -70 years
Each patient needs to agree with the study procedures.
Patients agree with the tests and examinations specified in the protocol.
Each patient should understand the purpose of the study and sign the informed consent document.
Exclusion criteria
High risk of relapse with aggression.
Serious illness other than schizophrenia, eg liver, kidney or gastrointestinal disorders, for which hospitalization is required within 9 months or leading to death within 3 years.
Severe suicidality.
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
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2009-013708-30-NL |
CCMO | NL28829.097.09 |