Cannabidiol for the treatment of patients at a high-risk of psychosis

CANnabidiol as a Treatment fOr clinical high-risk state Psychosis - a Randomised Clinical Trial (CANTOP-RCT)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10334895

Enrollment

300

Registered

2018-08-31

Start date

2022-09-01

Completion date

Unknown

Last updated

2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical high-risk for psychosis (CHR) Mental and Behavioural Disorders Clinical high-risk state for psychosis (CHR)

Interventions

Participants will be randomised into either the intervention or control group using block randomisation. Randomisation will be double-blind and stratified by site. Participants both gr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-35 2. Diagnosed with a clinical high-risk state for psychosis (CHR) 3. 'Attenuated psychotic symptoms' sub-group (CHR-APS) as defined using the CAARMS (Comprehensive Assessment of At-Risk Mental States) criteria

Exclusion criteria

Exclusion criteria: 1. History of a previous psychotic or manic episode lasting 7 days or more 2. Neurological disorders (e.g. epilepsy) or severe intercurrent illness 3. Current treatment with psychotropic medication or previous treatment with antipsychotic medication for more than 7 days 4. IQ of less than 70 5. Females who are pregnant, lactating or not using contraception

Design outcomes

Primary

Measure	Time frame
Change in the severity of psychotic symptoms, assessed using the Comprehensive Assessment of At-Risk Mental States (CAARMS) questionnaire at the baseline and at the end of the study (day 182)	—

Secondary

Measure	Time frame
The following will be assessed at the baseline and at the end of the study (day 182): 1. Changes in the distress associated with psychotic symptoms, assessed using the Comprehensive Assessment of At-Risk Mental States (CAARMS) questionnaire 2. Changes in the severity of anxiety symptoms assessed using the Hospital Anxiety and Depression Scale (HADS) and in the level of global functioning (assessed using the social and role functioning scale) 3. Clinical remission, as defined as no longer meeting the criteria for a diagnosis of clinical high-risk: attenuated psychosis syndrome using the CAARMS questionnaire	—

Measure

Time frame

The following will be assessed at the baseline and at the end of the study (day 182): 1. Changes in the distress associated with psychotic symptoms, assessed using the Comprehensive Assessment of At-Risk Mental States (CAARMS) questionnaire 2. Changes in the severity of anxiety symptoms assessed using the Hospital Anxiety and Depression Scale (HADS) and in the level of global functioning (assessed using the social and role functioning scale) 3. Clinical remission, as defined as no longer meeting the criteria for a diagnosis of clinical high-risk: attenuated psychosis syndrome using the CAARMS questionnaire

—

Countries

England, United Kingdom

Contacts

Public ContactSagnik Bhattacharyya

sagnik.2.bhattacharyya@kcl.ac.uk+44 (0)2078480002

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026