Schizophrenia Clinical Trial
Official title:
Relapse Prevention in First Episode of Schizophrenia and Related Psychotic Disorders: a 5 Year Randomized Controlled Trial
Objective: to evaluate the effectiveness of specialised and sustained intervention with or
without parent groups during the initial phase of schizophrenia or related disorders on
relapse prevention
Methods: A three conditions randomized trial with a duration of five years
Participants: 200 consecutively referred patients aged 15-28 years with a first psychotic
episode of schizophrenia or related disorder
Treatment-conditions: Specialized Treatment of early schizophrenia (ST), ST including Parent
groups (ST+P) and Treatment As Usual (TAU).
Outcome-measures: cumulative relapse rates and time to first relapse after first remission.
Secondary outcome measure: social functioning.
Statistical analysis: cumulative relapse rates using life-table methods. The effect of the
three interventions on time to first relapse after remission will be compared using Cox
regression analysing intention to treat (ITT) grouping.
Evidence for optimal duration and necessary ingredients of early and sustained specialized
treatment from first episode psychosis till the end of the initial phase schizophrenia is
still insufficient. Randomized trials with a treatment duration of six months to two years
with favorable symptomatic and psychosocial results disappeared at five year follow-up.
Other studies suggest that specialized treatment should last 5 years in order to be able to
prevent instead of only delaying clinical and psychosocial deteriorating.
In this study we examine both the symptomatic (relapse) and psychosocial outcome of a three
armed five year randomized trial in the initial phase of schizophrenia.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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