A randomized Phase II trial evaluating efficacy, safety, and tolerability of oral BI 409306 in attenuated psychosis syndrome: Design and rationale

Autor: Scott W. Woods, Stephane Pollentier, Dooti Roy, Philip McGuire, Tyrone D. Cannon, Daniel H. Mathalon, Michael Sand, Holger Rosenbrock, Kristen Daniels, Stephan Ruhrmann, Daniel Cotton, Richard S.E. Keefe
Jazyk: angličtina
Rok vydání: 2020
Předmět:
cognition
Psychosis
medicine.medical_specialty
Clinical Trials and Supportive Activities
Clinical Sciences
Placebo
03 medical and health sciences
0302 clinical medicine
Clinical Trials
Phase II as Topic
Rating scale
Clinical Research
Internal medicine
psychotic disorders
medicine
Psychology
Humans
Clinical Trials
Biological Psychiatry
Randomized Controlled Trials as Topic
Psychiatry
Positive and Negative Syndrome Scale
business.industry
Prevention
Phase II as Topic
Neurosciences
Evaluation of treatments and therapeutic interventions
Cognition
Original Articles
medicine.disease
Serious Mental Illness
Symptomatic relief
030227 psychiatry
Brain Disorders
schizophrenia
Psychiatry and Mental health
early intervention
Mental Health
Pyrimidines
Tolerability
Psychotic Disorders
Schizophrenia
6.1 Pharmaceuticals
Pyrazoles
Original Article
Pshychiatric Mental Health
business
phosphodiesterase
030217 neurology & neurosurgery
Zdroj: Early Intervention in Psychiatry
Early intervention in psychiatry, vol 15, iss 5
ISSN: 1751-7893
1751-7885
Popis: Author(s): Keefe, Richard SE; Woods, Scott W; Cannon, Tyrone D; Ruhrmann, Stephan; Mathalon, Daniel H; McGuire, Philip; Rosenbrock, Holger; Daniels, Kristen; Cotton, Daniel; Roy, Dooti; Pollentier, Stephane; Sand, Michael | Abstract: AimAttenuated psychosis syndrome (APS), a condition for further study in the Diagnostic and Statistical Manual of Mental Disorders-5, comprises psychotic symptoms that are qualitatively similar to those observed in schizophrenia but are less severe. Patients with APS are at high risk of converting to first-episode psychosis (FEP). As evidence for effective pharmacological interventions in APS is limited, novel treatments may provide symptomatic relief and delay/prevent psychotic conversion. This trial aims to investigate the efficacy, safety, and tolerability of BI 409306, a potent and selective phosphodiesterase-9 inhibitor, versus placebo in APS. Novel biomarkers of psychosis are being investigated.MethodsIn this Phase II, multinational, double-blind, parallel-group trial, randomized (1:1) patients will receive BI 409306 50 mg or placebo twice daily for 52 weeks. Patients (nn= 300) will be enrolled to determine time to remission of APS, time to FEP, change in everyday functional capacity (Schizophrenia Cognition Rating Scale), and change from baseline in Brief Assessment of Cognition composite score and Positive and Negative Syndrome Scale scores. Potential biomarkers of psychosis under investigation include functional measures of brain activity and automated speech analyses. Safety is being assessed throughout.ConclusionsThis trial will determine whether BI 409306 is superior to placebo in achieving sustainable remission of APS and improvements in cognition and functional capacity. These advances may provide evidence-based treatment options for symptomatic relief in APS. Furthermore, the study will assess the effect of BI 409306 on psychotic conversion and explore the identification of patients at risk for conversion using novel biomarkers.
Databáze: OpenAIRE
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