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J Clin Psychiatry. 2019 Jan 8;80(2). pii: 18m12495. doi: 10.4088/JCP.18m12495.

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

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The Zucker Hillside Hospital, Psychiatry Research, 75-59 263rd St, Glen Oaks, NY 11004.
Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, USA.
Department of Psychiatry and Molecular Medicine, Hofstra Northwell School of Medicine, New York, New York, USA.
Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin, Germany.
Department of Psychiatry and Human Behavior, University of California Irvine, Irvine, California, USA.
Allergan, Madison, New Jersey, USA.
Gedeon Richter Plc, Budapest, Hungary.



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.


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.


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).


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: identifier: NCT01412060.


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