discontinuation of combination antipsychotics to monotherapy: risk or added value?

Phase 4

Recruiting

Conditions: psychosis
schizophrenia
10039628

Registration Number: NL-OMON32961

Lead Sponsor: Symforagroep (Amersfoort)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 160

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study objective<br /><br>Is the reduction of 1 to several antipsychotic antipsychotic associated with<br /><br>more relapse?<br /><br>Relapse is measured with the Brief Psychiatric Rating Scale (BPRS) and is<br /><br>defined as:<br /><br>- An absolute increase of> 2 on one of the following BPRS items:<br /><br>disorganization, hallucinatory behavior, suspiciousness, unusual thought<br /><br>content, that specific items since the last visit, or<br /><br>- An absolute increase of> 4 in the BPRS total score of the following items:<br /><br>disorganization, hallucinatory behavior, suspiciousness, unusual thought<br /><br>content since the last visit. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study objectives<br /><br>1.Does reducing multiple antipsychotics to 1 antipsychotic affect symptoms of<br /><br>schizophrenia measured by the BPRS<br /><br>2. Does reducing multiple antipsychotics to 1 antipsychotic affect the number<br /><br>and nature of adverse events measured with the UKU<br /><br>3. Does reducing multiple antipsychotics to 1 antipsychotic affect metabolic<br /><br>parameters.<br /><br>4. Does reducing multiple antipsychotics to 1 antipsychotic affect symptoms of<br /><br>dyskinesia and EPS respectively measured with the AIMS, BARS and the UPDRS.<br /><br>5. Does reducing multiple antipsychotics to 1 antipsychotic affect the quality<br /><br>of life measured with the SWN<br /><br>6. Does reducing multiple antipsychotics to 1 antipsychotic affect the care<br /><br>needs measured by the Honos</p><br>