Stratification and Treatment in Early Psychosis Study - ENHANCE

Sponsor
University of Oxford
Study ID
NCT06778564
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • First Episode Psychosis
  • Psychosis
  • Psychotic Disorders
  • Psychotic Episode

Eligibility Criteria

Sex
ALL
Age
16 Years - 40 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 6 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

Study Details

The purpose of this study is: * To investigate whether the response to antipsychotic treatment can be enhanced by adding cannabidiol (CBD) to the existing treatment, compared to placebo, in participants with a first episode of psychosis, who have had a suboptimal or no response to their first antipsychotic treatment. * To confirm the safety of CBD in people with psychosis. The study is a randomized, double-blind, placebo-controlled, multi-centre, clinical trial. Individuals with a diagnosis of first-episode psychosis, who have had a suboptimal or no response to their first antipsychotic treatment will be recruited. These participants are randomised to treatment with CBD oral solution 500mg twice daily, or a matching placebo for 6 weeks, as an adjunct to their existing antipsychotic treatment. By using a battery of clinical outcome assessments, the trial will also assess several biomarkers to determine if they can be used 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 blood and stool samples, and may be asked to complete neuroimaging assessments at certain eligible sites.

Key Dates

First listed
Jan 16, 2025
Start date
Feb 28, 2026
Status verified
Dec 2024
Primary completion
Feb 29, 2028
Completion
Feb 28, 2029

Study Design

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

Arms

  • Experimental: Cannabidiol (CBD)
    Participants in this arm will receive Cannabidiol (CBD) for 6 weeks.
  • Placebo Comparator: Placebo
    Participants in this arm will receive placebo for 6 weeks.

Primary Outcome Measure

Change in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: 6 weeks ]

Central Contacts

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