Antipsychotic Combination with Psychosocial Intervention on Outcome of Schizophrenia (ACPIOS): Rationale and Design of the Clinical TrialAuthor(s): Xiaofeng Guo, Jingping Zhao, Zhening Liu, Jinguo Zhai, Zhimin Xue,Jindong Chen
Effective, long-term treatment of schizophrenic patients has many remaining unsolved problems. Pharmacotherapy alone is insufficient to prevent relapses or to ensure recovery from functional disabilities in the illness course. In an attempt to improve the long-term outcome for individuals with schizophrenia, there is a growing interest in psychosocial interventions as an adjunct to facilitate recovery from an initial episode of psychosis and reduce the long-term disability resulting from schizophrenia. The aim of the Antipsychotic Combination with Psychosocial Intervention on the Outcome of Schizophrenia (ACPIOS) project is to compare antipsychotic medication combination with psychosocial intervention to antipsychotic medication alone on the outcome of schizophrenia. A total of 1,400 patients with ages ranging between sixteen and fifty years who meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSMIV) criteria for schizophrenia and schizophreniform disorder for not more than five years are randomly assigned to either of the above two treatments. Relapse rates and the duration time from the start of treatment to the first relapse are recorded as a measure of the primary effectiveness of the respective treatment regimes. The study will be completed by mid-2008, and it is expected that the results will yield relevant clinical information on how antipsychotic combination with psychosocial intervention affects the outcome of schizophrenia. This paper sets out the rationale and the design of the trial.