Stratification and Treatment in Early Psychosis Study -ASSIST

Sponsor
University of Oxford
Study ID
NCT07326124
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Psychosis
  • Treatment Resistant Psychosis

Eligibility Criteria

Sex
ALL
Age
16 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

The purpose of this trial is: * To investigate whether the response to clozapine treatment can be enhanced by adding cannabidiol (CBD), compared to placebo, in treatment resistant psychosis patients. * To confirm the safety of CBD in people with psychosis. The trial is a randomised, double-blind, placebo-controlled, multi-centre, international, clinical trial. Individuals with a diagnosis of treatment resistant psychosis in their illness who have had a suboptimal or no response to clozapine treatment will be recruited. These patients are randomised to treatment with oral CBD 500mg twice daily, or a matching placebo for 12 weeks, in addition to clozapine, which is standard care treatment for this population. By using a battery of clinical outcome assessments, the trial will assess several optional biomarkers 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 additional blood samples, stool samples, and complete neuroimaging assessments.

Key Dates

First listed
Jan 8, 2026
Start date
Jun 30, 2026
Status verified
Nov 2025
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Cannobidiol
    Participants in this arm will receive Cannabidiol (CBD) for 12 weeks.
  • Placebo Comparator: Placebo
    Participants in this arm will receive placebo for 12weeks.

Primary Outcome Measure

Change in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: 12 weeks ]

Central Contacts

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