Evidence map›Paper›PMID 26655732›Full record

Trial reportInternational clinical psychopharmacology2016

Cariprazine in the treatment of schizophrenia: a proof-of-concept trial.

Suresh Durgam, Robert E Litman, Kelly Papadakis, Dayong Li, György Németh, István Laszlovszky

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International clinical psychopharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00404573 (A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia), which is not on this map. Cited by 38 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 10 pooled it
3.6field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00404573 phase2completednot on this map

A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia

TypeinterventionalSponsorForest LaboratoriesRan2006Enrolled375ConditionsSchizophreniaArmsRGH-188
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 10 syntheses or guidelines pooled it, 67 citations in OpenAlex.

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  5. New Antipsychotic Medications in the Last Decade.Current psychiatry reports · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Suresh DurgamDepartments of aClinical Development bBiostatistics, Forest Research Institute (an Allergan affiliate), Harborside Financial Center, Jersey City, New Jersey cCBH Health LLC, Rockville, Maryland, USA dMedical Division, Gedeon Richter Plc, Budapest, Hungary.
Robert E Litman
Kelly Papadakis
Dayong Li
György Németh
István Laszlovszky
Creative Commons · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Schizophrenic PsychologyAdultAntipsychotic AgentsDouble-Blind MethodFemaleHumansIntention to Treat AnalysisMaleMiddle AgedPiperazinesPsychiatric Status Rating ScalesSchizophreniaTime FactorsTreatment OutcomeUnited StatesAntipsychotic AgentscariprazinePiperazines

Identifiers

PMID26655732
PMCPMC4736298
OpenAlexW2320155748

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.