Stratification and Treatment in Early Psychosis Study - ENHANCE

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
PsychosisFirst Episode PsychosisPsychotic DisordersPsychotic Episode
Interventions
DRUG

CBD 100 mg/mL Oral Solution

Daily dose 1000mg, taken as 500mg (5ml) b.i.d for 6 weeks. For participants with a weight lower than 50 kg, the dose is to be adjusted to 20 mg/kg/day divided over 2 intakes of 10 mg/kg/day, for a period of 6 weeks

OTHER

Placebo

5ml b.i.d for 6 weeks; For participants with a weight lower than 50 kg, the dose is to be adjusted to 20 mg/kg/day divided over 2 intakes of 10 mg/kg/day, for a period of 6 weeks

Trial Locations (17)

Unknown

MedUni Vienna, Vienna

University of Augsburg, Augsburg

Charité Universitätsmedizin, Berlin

University Hospital Cologne, Cologne

Ludwig-Maximilian-University Munich, Munich

National and Kapodistrian University of Athens, Athens

Shalvata Mental Health Center, Hod HaSharon

Geha Mental Health Center, Petah Tikva

Sheba Medical Centre, Ramat Gan

University of Campania 'Luigi Vanvitelli', Napoli

Stichting Amsterdam UMC, Amsterdam

Hospital General Universitario Gregorio Marañón, Madrid

Hospital Universitario Virgen del Rocío, Seville

Psychiatric University Hospital (PUK), Zurich, Zurich

Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge

West London NHS Trust, London

Oxford Health NHS Foundation Trust, Oxford

All Listed Sponsors
collaborator

Wellcome Trust

OTHER

collaborator

GW Pharmaceuticals Ltd

INDUSTRY

collaborator

Myonex

UNKNOWN

collaborator

Cambridge Cognition Ltd

INDUSTRY

collaborator

Premier Research

OTHER

collaborator

Diagram B.V.

OTHER

collaborator

Cambridgeshire and Peterborough NHS Foundation Trust

OTHER

collaborator

Oxford Health NHS Foundation Trust

OTHER_GOV

collaborator

West London NHS Trust

OTHER

collaborator

University of Augsburg

UNKNOWN

collaborator

Charite University, Berlin, Germany

OTHER

collaborator

University of Cologne

OTHER

collaborator

Ludwig Maximilian university of Munich

UNKNOWN

collaborator

The Sheba Fund for Health Services and Research

UNKNOWN

collaborator

Shalvata Mental Health Center

OTHER

collaborator

Geha Mental Health Center

OTHER

collaborator

Amsterdam University Medical Center

OTHER

collaborator

Hospital General Universitario Gregorio Marañon

OTHER

collaborator

National and Kapodistrian University of Athens

OTHER

collaborator

Medical University of Vienna

OTHER

collaborator

Hospitales Universitarios Virgen del Rocío

OTHER

collaborator

University of Campania Luigi Vanvitelli

OTHER

collaborator

Swansea University

OTHER

collaborator

Psychiatric University Hospital, Zurich

OTHER

collaborator

IDEA Regulatory

UNKNOWN

lead

University of Oxford

OTHER