Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CBD/mL · 2 trials · 5 indications
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. |
| Cannabidiol (CBD) | EXPERIMENTAL | Participants in this arm will receive Cannabidiol (CBD) for 6 weeks. |
| 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 |
| Placebo | OTHER | 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 |
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...
CBD/mL is an investigational oral solution being developed for psychosis and treatment resistant psychosis. It is a small molecule being studied in patients with early psychosis and psychotic disorders. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
CBD/mL is a small molecule being developed for psychiatric conditions. The specific molecular target of CBD/mL has not been disclosed in available information. The drug is being studied for its effects on psychosis and treatment resistant psychosis in clinical trials.
CBD/mL is being developed by Cognition Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol CGTX. The company is conducting Phase 3 clinical trials to evaluate the drug for the treatment of psychosis and treatment resistant psychosis.
CBD/mL is currently in Phase 3 clinical development. It is being studied in two Phase 3 trials for psychosis and treatment resistant psychosis. The drug is investigational and has not yet received regulatory approval for any indication.
CBD/mL is being evaluated in two Phase 3 clinical trials. The ENHANCE study (NCT06778564) is investigating the drug in early psychosis, while the ASSIST study (NCT07326124) is focused on treatment resistant psychosis. Both trials are randomized, double-blind, placebo-controlled studies with a planned enrollment of 250 participants each.
Yes, CBD/mL is also known as CBD 100 mg/mL Oral Solution. This alternative name refers to the same investigational drug being developed by Cognition Therapeutics for the treatment of psychosis and treatment resistant psychosis.