Abstract
Introduction: Over the last fifteen years, valid and reliable criteria have been developed for identifying individuals at ‘ultra-high risk’ (UHR) of imminent onset of psychotic disorder. A number of randomized controlled trials (RCTs) have been conducted in the UHR population. These trials have demonstrated that psychotic disorder can at least be delayed in this population. However, it remains unclear what the most effective type, timing and duration of treatment is for this population is. There is evidence that benign treatments may be sufficient as a first step in the UHR population. Recent research also indicates a reduction in rate of transition to psychotic disorder in the UHR population. Together, these data suggests that a staged approach to treatment, starting with more benign interventions and progressing to more intensive treatments in the case of poor response or deterioration, may be appropriate for the UHR population. Another factor that has been a challenge in UHR intervent ion studies has been to recruit a sufficient number of participants to provide statistical power to address research questions. Methods: This background has provided the impetus for a new multisite RCT being developed in the UHR population. The RCT has a two-stage design. Stage 1 consists of participants being randomized to one of two conditions: cognitive-behavioural case management (CBCM) + placebo or CBCM + eico sapentanoic acid (EPA). Treatment will continue for 3 months. Participants who fail to respond to treatment in Stage 1 will be randomized at Stage 2 to either CBCM + low dose atypical anti-psychotic medication (quetiapine) or CBCM + placebo. Treatment will continue for 6 months. The study will be conducted across 9 international UHR clinics.
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