Universität zu Köln

Keefe, Richard S. E., Woods, Scott W., Cannon, Tyrone D., Ruhrmann, Stephan, Mathalon, Daniel H., McGuire, Philip, Rosenbrock, Holger, Daniels, Kristen, Cotton, Daniel, Roy, Dooti, Pollentier, Stephane and Sand, Michael . A randomized Phase II trial evaluating efficacy, safety, and tolerability of oral BI 409306 in attenuated psychosis syndrome: Design and rationale. Early Interv. Psychiatry. HOBOKEN: WILEY. ISSN 1751-7893

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Abstract

Aim Attenuated 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. Methods In 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 (n = 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. Conclusions This 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Keefe, Richard S. E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Woods, Scott W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cannon, Tyrone D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ruhrmann, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Mathalon, Daniel H. UNSPECIFIED UNSPECIFIED UNSPECIFIED McGuire, Philip UNSPECIFIED UNSPECIFIED UNSPECIFIED Rosenbrock, Holger UNSPECIFIED UNSPECIFIED UNSPECIFIED Daniels, Kristen UNSPECIFIED UNSPECIFIED UNSPECIFIED Cotton, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED Roy, Dooti UNSPECIFIED UNSPECIFIED UNSPECIFIED Pollentier, Stephane UNSPECIFIED UNSPECIFIED UNSPECIFIED Sand, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-307563
DOI:	10.1111/eip.13083
Journal or Publication Title:	Early Interv. Psychiatry
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1751-7893
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CLINICAL HIGH-RISK; PHOSPHODIESTERASE 9A INHIBITOR; EARLY INTERVENTION; EPA GUIDANCE; SCHIZOPHRENIA; PREDICTION; PEOPLE; YOUTH; PHARMACOKINETICS; RELIABILITY Multiple languages Psychiatry Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/30756