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

discontinuation of combination antipsychotics to monotherapy: risk or added value? - ACiS (Antipsychotic Combinations in Schizophrenia)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32961
Enrollment
160
Registered
2009-09-02
Start date
2010-04-28
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psychosis schizophrenia

Interventions

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

Sponsors

Symforagroep (Amersfoort)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)