UKRAINS'KYI VISNYK PSYKHONEVROLOHII

The Scientific and Practical Journal of Medicine
ISSN 2079-0325(p)
DOI 10.36927/2079-0325
Home » Archive of numbers » 2020 » Volume 28, issue 3 (104) » Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial

Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial

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Type of Article

  • Scientific Article

In the Section

  • ORIGINAL RESEARCH

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Index UDK:
  • 616.895.8--071-036.65-039.71

Abstract

Cariprazine, a dopamine D3/D2 partial agonist with preferential affinity for dopamine D3 receptors, has demonstrated efficacy in randomized controlled trials in schizophrenia. This multinational, randomized, double-blind, placebo-controlled, parallel-group study assessed the efficacy, safety, and tolerability of cariprazine for relapse prevention in adult patients with schizophrenia. The study duration was up to 97 weeks. Schizophrenia symptoms were relieved/stabilized with cariprazine 3-9 mg/day during a 20-week open-label treatment phase consisting of an 8-week flexible-dose run-in phase and a 12-week fixed-dose stabilization phase. Patients who completed open-label treatment and were stable were randomized to a double-blind subsequent treatment phase (up to 72 weeks): one group continued to receive cariprazine (at a fixed dose of 3, 6, or 9 mg/day) or the other group received placebo. The primary efficacy parameter was time to relapse (worsening of symptom scores, psychiatric hospitalization, aggressive/violent behavior, or risk of suicidal ideation or actions). Appropriate clinical measures were taken to ensure safety in case of relapse. A total of 264 of 765 patients completed the open-label treatment phase. A total of 200 patients who met the inclusion criteria were randomized to the double-blind subsequent treatment phase: 99 to the placebo group and 101 to the cariprazine group. The time to relapse was significantly longer in patients receiving cariprazine than in patients receiving placebo (P = 0.0010, by log-rank test). Relapse occurred in 24.8% of patients receiving cariprazine and 47.5% of patients receiving placebo (odds ratio [95% CI] = 0.45 [0.28 to 0.73]). Adverse events during the open-label treatment phase were reported in ≥ 10% of patients: 19.2% of patients experienced akathisia, 14.4% experienced insomnia, and 12.0% experienced headache. No adverse events were observed with cariprazine during the double-blind treatment phase. Long-term treatment with cariprazine demonstrated significantly greater efficacy than placebo in preventing relapse in patients with schizophrenia. The long-term safety profile in this study was consistent with that observed in previous clinical trials of cariprazine. The ClinicalTrials.gov identifier for this clinical trial is NCT01412060.

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  • 27-37

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UKRAINS'KYI VISNYK PSYKHONEVROLOHII

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