Effect of experimental endocannabinoid modulation on brain function in individuals at high risk for psychosis

Phase 1

Completed

• Conditions: ltra high risk for psychosis; Mental and Behavioural Disorders; Ultra high risk for psychosis

• Registration Number: ISRCTN46322781
• Lead Sponsor: King's College London

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30167644 results 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32921794/ (added 08/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-12
• Study Completion: 2017-02-28
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 33

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).