Cariprazine in the treatment of schizophrenia: a proof-of-concept trial
| Autor: | Kelly Papadakis, Robert E. Litman, György Németh, Suresh Durgam, Dayong Li, István Laszlovszky |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors cariprazine Cariprazine Akathisia Placebo Piperazines law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial Double-Blind Method law Extrapyramidal disorder Internal medicine medicine Humans Pharmacology (medical) Psychiatry Psychiatric Status Rating Scales dopamine D3 Positive and Negative Syndrome Scale Original Articles Middle Aged medicine.disease United States 030227 psychiatry Intention to Treat Analysis antipsychotic schizophrenia Psychiatry and Mental health Treatment Outcome chemistry Tolerability Schizophrenia Female Schizophrenic Psychology medicine.symptom Psychology 030217 neurology & neurosurgery Antipsychotic Agents |
| Zdroj: | International Clinical Psychopharmacology |
| ISSN: | 1473-5857 |
| Popis: | This 6-week, double-blind, placebo-controlled, proof-of-concept study evaluated the efficacy, safety, and tolerability of low-dose (1.5-4.5 mg/day) and high-dose (6-12 mg/day) cariprazine in patients with acute exacerbation of schizophrenia (NCT00404573). The primary efficacy measure was change in the Positive and Negative Syndrome Scale (PANSS) total score, analyzed using a last observation carried forward approach. Other efficacy measures included the Clinical Global Impression-Severity (secondary) and PANSS subscales (additional). There were no significant differences between the two doses of cariprazine and placebo in PANSS total score change or any other efficacy parameter after multiplicity adjustment. However, low-dose cariprazine versus placebo showed significantly greater reductions in PANSS total (P=0.033) and PANSS negative (P=0.027) scores without multiplicity adjustment. Common treatment-emergent adverse events (incidence≥5% and twice that in the placebo group in either cariprazine dose group) were akathisia, restlessness, tremor, back pain, and extrapyramidal disorder. In this study, the overall cariprazine treatment effect was not statistically significant, but patients treated with low-dose cariprazine showed significantly greater improvement in schizophrenia symptoms relative to placebo-treated patients. Cariprazine was generally well tolerated. Results of this study suggest that cariprazine may be effective in treating schizophrenia and future research is warranted. |
| Databáze: | OpenAIRE |
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