Ultra high risk for psychosis Mental and Behavioural Disorders Ultra high risk for psychosis
Conditions
Interventions
Participants will be randomly allocated to one of the two treatment arms using a blocked randomisation list with a 1:1 allocation ratio.
Intervention arm: Participants receive oral ad
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18- 35 years 2. Right-handed 3. Ultra high risk (UHR) for psychosis individuals being supported by OASIS (https://www.oasislondon.com), a large clinical service for this group 4. Have positive psychotic symptoms and anxiety symptoms, as defined using the Positive and Negative syndrome scale (PANSS) and the State-Trait Anxiety Inventory (STAI) 5. Medication naïve
Exclusion criteria
Exclusion criteria: 1. History of previous psychotic disorder or manic episode 2. Current DSM IV diagnosis of substance dependence (except cannabis dependence) 3. Neurological disorders (eg., epilepsy) or severe intercurrent illness that may put the person at risk 4. IQ of less than 70 5. Female subject who is unwilling to use two forms of contraception (one of which must be a barrier contraception), pregnant, lactating or planning pregnancy during the course of the study and 3 months from the date of the last dose and a male subject whose partner is of child-bearing potential and unwilling to use a barrier method of contraception along with their partner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fMRI BOLD signal in the hippocampus, striatum and amygdala measured during the memory, salience and emotional (fear) processing tasks on day 1 and day 21. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma endocannabinoid (Anandamide, 2-AG, OEA, PEA) levels measured on day 1 (110 minutes following drug administration on day 1) and day 21 (110 minutes following administration of the last dose of the drug). | — |
Countries
England, United Kingdom
Outcome results
None listed