Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07434973 | Stratification and Treatment in Early Psychosis Study - PROMOTE | PHASE3 | NOT YET_RECRUITING | 586 | — | — | May 1, 2026 | Dec 1, 2031 | Feb 27, 2026 | 19 | Austria, Canada +8 |
Change from baseline to Week 104 in the positive symptom subscale score (P1-P4) of the Comprehensive Assessment of At-Risk Mental States (CAARMS). Higher scores indicate greater symptom severity.
| Arm | Type | Description |
|---|---|---|
| Cannabidiol 100g/ml oral solution | ACTIVE_COMPARATOR | Participants will take the intervention for 106 weeks (104 weeks plus a 2-week taper). Doses depend on age and weight: Adults (16 years and older) over 50kg: daily dose 600mg (6ml); 300mg (3ml) twice a day (b.i.d); Adults (16 years and older) less than 50kg: daily dose 10mg/kg; 5mg/kg twice a day (b.i.d); Children (\<16 years old): daily dose 5mg/kg twice a day (b.i.d), following on from a two-week rapid titration schedule. n=188 |
| Placebo | PLACEBO_COMPARATOR | Participants will take the intervention for 106 weeks (104 weeks plus a 2-week taper). Doses depend on age and weight: Adults (16 years and older) over 50kg: daily dose 600mg (6ml); 300mg (3ml) twice a day (b.i.d). Adults (16 years and older) less than 50kg: daily dose 10mg/kg; 5mg/kg twice a day (b.i.d). Children (\<16 years old): daily dose 5mg/kg twice a day (b.i.d), following on from a two-week rapid titration schedule. n=188 |
| Healthy controls | NO_INTERVENTION | A healthy control in the context of this trial is someone who does not meet CHR-P criteria or have a diagnosis of a mental health condition. They will not take the trial intervention and attend one trial visit for clinical assessments and biomarker sampling only. n=150 |
| Name | Type | Description |
|---|---|---|
| Cannabidiol (CBD) | DRUG | CBD 100 mg/mL Oral Solution |
| Placebo | DRUG | Placebo for Cannabidiol oral solution 100mg/mL oral solution |
CHR-P patients: Inclusion Criteria 1. 12 to 35 years of age inclusive, willing and able to provide written informed consent/assent. 2. Meet criteria for either the Attenuated Psychotic Symptoms (APS) or Brief Limited Intermittent Psychotic Symptoms (BLIPS) subgroups of the CHR-P state, defined usi...