Long-Term Remission With Cariprazine Treatment in Patients With Schizophrenia: A Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Trial.

BACKGROUND: Long-term remission is an important treatment goal in schizophrenia. Cariprazine, a dopamine D₃/D₂ receptor and serotonin 5-HT1A receptor partial agonist, is approved in the United States and Europe to treat adults with schizophrenia.

METHODS: Post hoc analyses of data from a long-term cariprazine relapse prevention study (NCT01412060; September 27, 2011-September 3, 2014) investigated the efficacy of cariprazine for maintaining remission in clinically stable patients with DSM-IV-TR-defined schizophrenia. Patients were stabilized with open-label cariprazine (20 weeks), then randomized 1:1 to cariprazine (3, 6, or 9 mg/d) or placebo for double-blind treatment (up to 72 weeks). Symptomatic remission was defined as scores ≤ 3 on 8 items from the General, Positive, and Negative Symptoms subscales of the Positive and Negative Syndrome Scale (PANSS). Sustained remission included meeting remission criteria at the current and all prior double-blind visits or for ≥ 6 consecutive months.

RESULTS: At randomization, 169/200 patients (84.5%) met symptomatic remission criteria. During double-blind treatment, time to loss of sustained remission was significantly longer (P = .0020) for cariprazine versus placebo (hazard ratio = 0.51); 60.5% of cariprazine-treated and 34.9% of placebo-treated patients sustained remission through the final visit (odds ratio [OR] = 2.85; P = .0012; number needed to treat [NNT] = 4). Almost twice as many cariprazine-treated (39.6%) as placebo-treated (21.2%) patients met symptomatic remission criteria at all visits ≥ 6 consecutive months immediately before/including the final double-blind visit (OR = 2.44; P = .0057; NNT = 6). More cariprazine-treated (41.6%) than placebo-treated (27.3%) patients sustained remission for any ≥ 6 consecutive month period (OR = 1.90, P = .0379; NNT = 7).

CONCLUSIONS: Cariprazine was associated with significantly longer sustained remission, higher remission rates, and increased likelihood of sustaining remission for ≥ 6 consecutive months versus placebo.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01412060.