108. PREVENT: A Randomized Controlled Trial for the Prevention of First-Episode Psychosis Comparing Cognitive–Behavior Therapy (CBT) Clinical Management and Aripiprazole Combined and Clinical Management and Placebo Combined

摘要

>Background: Although there are encouraging results from clinical trials focusing on second generation antipsychotics, omega-3-fatty acids or psychotherapy for the prevention of psychosis, their empirical evidence remains uncertain and it is unknown whether these interventions are comparable in reducing the risk of conversion to psychosis in persons at clinical high risk (CHR).Therefore, the present multicenter, prospective, randomized, blinded trial with three parallel groups (PREVENT) was designed to explore the differential preventive efficacy of two approaches 1. cognitive behavioral therapy (CBT) and 2. Aripiprazole (ARI) + clinical management (CM) to 3. placebo (PL) + CM. >Methods: Individuals aged 18–49 identified as CHR by Ultra-High-Risk and/or basic symptoms COGDIS criteria were assessed at baseline, 28 and 52 weeks. The primary outcome was progression to psychosis including transition to psychosis or conversion from early initial prodromal state (defined by COGDIS or decline of functioning in combination with family risk factors or schizotypal disorder) to late initial prodromal state (defined by the presence of attenuated positive symptoms or brief limited intermittent psychotic symptoms). Secondary outcome was transition to psychosis. >Results: Of 611 eligible individuals 280 were randomized. The Full analysis set comprised 216 individuals [mean age 24.4 (5.1) years; about 66 % male]. In terms of the primary outcome, there was a clinical relevant difference between the three treatment arms (CBT: 19.2 %; AR+CM: 26.8 %; PL+CM: 30.0 %), but no statistical difference (P > .05). Pairwise comparisons showed a statistical trend in favor of CBT compared with CM + PL. With respect to the secondary outcome, there was a reduction in favor of CBT compared to CM + ARI also on a statistical trend level. Drop-out rates differed between the arms over time (P < .05), with indications for more premature terminations in ARI + CM and PL + CM compared to CBT. >Conclusion: Pairwise comparisons showed a clinically relevant reduction regarding the primary (about 30%) and secondary outcome (about 40%) in favor of CBT. Lower drop-out rates in CBT could be interpreted as higher adherence and acceptance of psychotherapy within this trial.