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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07326124 | Stratification and Treatment in Early Psychosis Study -ASSIST | PHASE3 | NOT YET_RECRUITING | 250 | — | — | Jun 1, 2026 | Sep 1, 2029 | Jan 8, 2026 | 15 | Germany, Greece +6 |
Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to 12 weeks. The minimum value is 1 and the maximum value is 7 for each item of the scale. 1. A patient meets remission criteria if none of the following items score a 4 or higher: P1, P2, P3, N1, N4, N6, G5 and G9. 2. A patient does not meet remission criteria if one or more of these items score a 4 or higher.
| Arm | Type | Description |
|---|---|---|
| Experimental: Cannobidiol | EXPERIMENTAL | Participants in this arm will receive Cannabidiol (CBD) for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants in this arm will receive placebo for 12weeks. |
| Name | Type | Description |
|---|---|---|
| CBD 100 mg/mL Oral Solution | DRUG | 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 12 weeks |
| Placeb | DRUG | 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 12 weeks |
Inclusion Criteria: Participation in the trial requires meeting all of the following inclusion criteria: 1. 16 to 50 years of age (inclusive) who are willing and able to provide written informed consent/assent (country specific requirements apply). 2. The patient has been treated with clozapine for...