Stratification and Treatment in Early Psychosis Study - ENHANCE
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16-40
SponsorUniversity of Oxford
About this trial
The purpose of this study is:
* To investigate whether the response to antipsychotic treatment can be enhanced by adding cannabidiol (CBD) to the existing treatment, compared to placebo, in participants with a first episode of psychosis, who have had a suboptimal or no response to their first antipsychotic treatment. * To confirm the safety of CBD in people with psychosis.
The study is a randomized, double-blind, placebo-controlled, multi-centre, clinical trial. Individuals with a diagnosis of first-episode psychosis, who have had a suboptimal or no response to their first antipsychotic treatment will be recruited. These participants are randomised to treatment with CBD oral solution 500mg twice daily, or a matching placebo for 6 weeks, as an adjunct to their existing antipsychotic treatment. By using a battery of clinical outcome assessments, the trial will also assess several biomarkers to determine if they can be used to predict clinical outcomes and response to treatment with CBD. Biomarkers are being assessed as an exploratory outcome measure. Participants will be invited to provide blood and stool samples, and may be asked to complete neuroimaging assessments at certain eligible sites.
Eligibility criteria
Qualifiers
The participant is 16 to 40 years of age, willing and able to provide written informed consent/assent.
The participant is currently being treated with an antipsychotic for at least 3 weeks but no longer than 16 weeks.
The participant should be receiving at least the minimum dose of this antipsychotic for FEP according to modified Maudsley guidelines, as listed in Appendix B. The clinician should judge the participant to be a non-responder to this treatment and that increasing the dose further is unacceptable to the clinician and/or participant.
The compliance score associated with this antipsychotic medication is 4 or more on the Clinician Rating Scale (CRS).
Disqualifiers
Having been previously treated with a different antipsychotic (to the current one) at an adequate dose* for 4 weeks or longer.
Current or previous treatment with clozapine and/or current treatment with sodium valproate, valproate semisodium, or clobazam. In cases of current use of these medicines, participation is only permitted if they can and will be discontinued or switched to a suitable alternative medication prior to randomisation.
Hypersensitivity to the active substance, sesame oil, sesame seed or any of the excipients of the intervention.
Known hepatic insufficiency and/or transaminase elevations levels exceeding the upper limit of normal 2 times or more and bilirubin greater than 1.5 times the upper limit of normal.
Trial design
Treatments tested in this trial
- CBD 100 mg/mL Oral Solution
- Placebo
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Oxford
Lead sponsor
Wellcome Trust
Collaborator
Cambridge Cognition Ltd
Collaborator
Cambridgeshire and Peterborough NHS Foundation Trust
Collaborator
Oxford Health NHS Foundation Trust
Collaborator
West London NHS Trust
Collaborator
Charite University, Berlin, Germany
Collaborator
University of Cologne
Collaborator
Ludwig-Maximilians - University of Munich
Collaborator
The Sheba Fund for Health Services and Research
Collaborator
Shalvata Mental Health Center
Collaborator
Geha Mental Health Center
Collaborator
Amsterdam University Medical Center
Collaborator
Hospital General Universitario Gregorio Marañon
Collaborator
National and Kapodistrian University of Athens
Collaborator
Medical University of Vienna
Collaborator
Hospitales Universitarios Virgen del Rocío
Collaborator
University of Campania Luigi Vanvitelli
Collaborator
Psychiatric University Hospital, Zurich
Collaborator
Source ClinicalTrials.gov