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

Abstract

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.

• Authors: Christoph U Correll, Steven G Potkin, Yan Zhong, Judit Harsányi, Balázs Szatmári, Willie Earley
• Journal: The Journal of clinical psychiatry (J Clin Psychiatry) Vol. 80 Issue 2 (01 08 2019) ISSN: 1555-2101 [Electronic] United States
• PMID: 30695290 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © Copyright 2019 Physicians Postgraduate Press, Inc.

Chemical References

• Antipsychotic Agents
• Piperazines
• cariprazine

Topics

• Adult
• Antipsychotic Agents (therapeutic use)
• Double-Blind Method
• Female
• Humans
• Male
• Piperazines (therapeutic use)
• Schizophrenia (drug therapy)
• Secondary Prevention
• Time Factors
• Treatment Outcome
• Young Adult