None listed
Conditions
Brief summary
The study will be a randomised, placebo-controlled double-blind parallel-group trial; over a 12 week period. The primary objective in this study is to determine the impact of a 12 week treatment of CBD on the PANSS positive score in patients with clozapine refractory schizophrenia compared to placebo. Specifically, it is hypothesised those participants allocated to the active arm CBD treatment will have meaningful difference in PANSS positive score of at least 1.8 at week 12 compared to individuals taking placebo.
Interventions
The study will include 88 individuals with schizophrenia or schizoaffective disorder who will be randomised to receive daily 1000mg Cannabidiol or placebo for 12 weeks in addition to their normal routine care. Routine care is defined as 'individualized combinations of psychopharmacology, behavioural interventions, rehabilitation and associated clinical services in keeping with Queensland Health standards of care'.
All unused supplies of study medication (i.e. oral capsules), will be accounted
The study will include 88 individuals with schizophrenia or schizoaffective disorder who will be randomised to receive daily 1000mg Cannabidiol or placebo for 12 weeks in addition to their normal routine care. Routine care is defined as 'individualized combinations of psychopharmacology, behavioural interventions, rehabilitation and associated clinical services in keeping with Queensland Health standards of care'. All unused supplies of study medication (i.e. oral capsules), will be accounted for and documented by the designated Research Pharmacist. Compliance with study medication will be documented at each visit by means of a capsule count.
Sponsors
The University of Queensland
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
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18 and 64 years (inclusive). 2. Fulfil the DSM-IV criteria for schizophrenia or schizoaffective disorder, based on the Diagnostic Interview for Psychosis (DIP) 3. Total PANSS score greater than or equal to 60 4. Have received oral clozapine for a period of at least 18 weeks with a clozapine level of greater than 350mg/ml 5. Agree to participate, has capacity to consent and able to follow the study instructions and procedures.
Exclusion criteria
1. Pregnancy, lactation, or if sexually active, no effective contraception (applies to both male and female participants) 2. Clinical blood test findings that might compromise participant safety or confound the trial results 3. Active current substance misuse including amphetamine and cannabis use 4. Other prescribed cannabinoids 5. Severe disturbance, such that the person is unable to comply with either the requirements of informed consent or the treatment protocol 6. Any concomitant disease or condition that according to the investigator’s assessment makes the patients unsuitable for trial participation 7. Cessation of clozapine
Outcome results
None listed