None listed
Conditions
Brief summary
This study will test whether cannabidiol (CBD) alongside antipsychotic medication can reduce psychotic symptom severity in young people with first episode psychosis (FEP) for whom antipsychotic treatment is not showing efficacy. CBD has been shown to reduce psychotic symptoms in adults with schizophrenia. It is non-intoxicating and non-addictive with a high margin of safety, and its side-effect profile is far superior to that of antipsychotic medications. This will be the first study to test its efficacy in FEP. Consenting 15-25 year-olds with FEP who have not responded to at least one adequate trial of antipsychotic medication and are within 2 weeks of commencing a new antipsychotic medication will be randomised to receive either 1000mg of CBD or placebo per day for 12 weeks in addition to their current antipsychotic medication and clinical care.
Interventions
For 12 weeks, participants will receive daily oral doses of 1000 mg cannabidiol (CBD) or matched placebo, on a fixed schedule. Participants will continue to receive treatment as usual (TAU) with their current mental health provider during study treatment phase. All capsules will be identical containing 200mg of CBD or placebo, with participants instructed to take five capsules per day (two in the morning and three in the afternoon).
Treatment as usual will comprise antipsychotic medication an
For 12 weeks, participants will receive daily oral doses of 1000 mg cannabidiol (CBD) or matched placebo, on a fixed schedule. Participants will continue to receive treatment as usual (TAU) with their current mental health provider during study treatment phase. All capsules will be identical containing 200mg of CBD or placebo, with participants instructed to take five capsules per day (two in the morning and three in the afternoon). Treatment as usual will comprise antipsychotic medication and psychosocial treatment. Concomitant medication and psychosocial treatment type and frequency will be documented throughout the intervention period. Treatment adherence will be assessed by regular capsule counts over the course of the study and objective quantification of cannabinoid levels in regular urine samples throughout treatment. Participants will also be asked to self-report their compliance at scheduled research assessments.
Sponsors
Orygen, The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
15 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 15-25 (inclusive) at entry; 2. Ability to give informed consent and adhere to study procedures (parental or guardian consent will be obtained for those aged <18 years); 3. Sufficient fluency in English for consent and assessment purposes); 4. First treated episode of a DSM-5 psychotic disorder; 5. Young people who meet criteria for first episode psychosis who have not responded to at least one adequate trial of antipsychotic medication and are within 2 weeks of having commenced a new antipsychotic medication 6. PANSS total score >70 corresponding to inadequate response to antipsychotic medication.
Exclusion criteria
1. Prior sensitivity or allergy to CBD or any cannabis-derived product; 2. If prescribed psychotropic medication (other than antipsychotic) the individual must have been on a stable dose for a minimum of 2 weeks; 3. Pregnancy, lactation, or if sexually active, no effective contraception; 4. Clinical blood test findings that might compromise participant safety or confound the trial results; 5. Acute or unstable systemic medical disorder; 6. Psychiatric condition due to a medical condition; 7. Severe disturbance, such that the person is unable to comply with either the requirements of informed consent or the treatment protocol.; 8. Diagnosis of a serious developmental disorder or a documented history of developmental delay or intellectual disability; 9. More than 3 months of continual prior antipsychotic medication use; 10. Psychotic symptoms only present during acute intoxication.
Outcome results
None listed