First Episode Psychosis (FEP)
Conditions
Brief summary
Primary endpoint treatment period is the change in total PANSS score after 6 weeks of CBD or placebo treatment as an adjunct to standard treatment relative to baseline.
Detailed description
Treatment period: PANSS; CDSS, HAM-A, OASIS; WHOQOL_BREF and EQ-5D-3L; SOFAS and FROGS; All-cause discontinuation; GASS and adverse event reporting; CGI-S, CGI-I, PGI-I, PGI-S; PsyCog Battery; Biomarkers Long-term Follow-up period: PANSS; WHOQOL_BREF and EQ-5D-3L; SOFAS, FROGS, GF:S/R; CGI-S, CGI-I, PGI-I, PGI-S Biomarkers: (Epi)genetics, proteomics, inflammation, metabolomics, Redox markers, microbiome, neuroimaging (MRI/MRS) measures, PANSS
Interventions
DRUGCANNABIDIOL
DRUGPlacebo oral solution with beta-carotene. The placebo has no marketing authorisation
DRUGas it does not contain an active substance. it is produced solely for clinical trial use under good manufacturing practice (GMP).
Sponsors
University Of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint treatment period is the change in total PANSS score after 6 weeks of CBD or placebo treatment as an adjunct to standard treatment relative to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment period: PANSS; CDSS, HAM-A, OASIS; WHOQOL_BREF and EQ-5D-3L; SOFAS and FROGS; All-cause discontinuation; GASS and adverse event reporting; CGI-S, CGI-I, PGI-I, PGI-S; PsyCog Battery; Biomarkers Long-term Follow-up period: PANSS; WHOQOL_BREF and EQ-5D-3L; SOFAS, FROGS, GF:S/R; CGI-S, CGI-I, PGI-I, PGI-S Biomarkers: (Epi)genetics, proteomics, inflammation, metabolomics, Redox markers, microbiome, neuroimaging (MRI/MRS) measures, PANSS | — |
Outcome results
None listed