A Phase 3 interventional study of CBD 100 mg/mL Oral Solution and Placebo in Psychosis, First Episode Psychosis and Psychotic Disorders, sponsored by University of Oxford. Recruiting at 17 sites in 9 countries. Open to participants aged 16 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by University of Oxford · Phase 3, Interventional, and Treatment
Among 11 studies testing cannabidiol in Psychotic Disorders — 4 open to participants now, 5 under way, 4 of them phase 3. Cannabidiol · Psychotic Disorders.
Among the 11 studies testing cannabidiol in Psychotic Disorders, this one is the 2nd largest by planned enrollment, is one of 2 that started in 2026, is one of 4 in phase 3, and was the 9th registered.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
Browse Psychotic Disorders studies →4 of the 11 studies testing cannabidiol in Psychotic Disorders are open now, in 12 countries. Recruiting first, the newest first:
University of California, San Diego · Sites in United States
University of Oxford · Sites in Germany, Greece, Israel and 5 more countries
University of Oxford · Sites in Austria, Canada, Finland and 7 more countries
By country, each count listing its studies:
Cannabidiol: first FDA approval 2018 (EPIDIOLEX), first EMA approval 2019. What it is approved for, and how studies give it, is on its page →
Of the 205 Psychotic Disorders studies recruiting now, 53 (26%) set no upper age limit and 143 (70%) stop at 75 or younger; 51 take children under 18; 41 take healthy volunteers.
This study: 16 Years to 40 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 250 is above the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
Median enrollment 64 across the 11 interventional studies. Of the 5 that completed or were terminated, 4 (80%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 11 has an industry lead sponsor. The 6 most frequent:
University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
University of Oxford has 4 studies filed under Psychotic Disorders — fewer than ten, so there is no comparison to draw.
1 of the studies testing cannabidiol in Psychotic Disorders that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04411225Phase 3University of California, San DiegoEffects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis | 2026-12 |
Among the 11 studies testing cannabidiol in Psychotic Disorders, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study is:
The study is a randomized, double-blind, placebo-controlled, multi-centre, clinical trial. Individuals with a diagnosis of first-episode psychosis, who have had a suboptimal or no response to their first antipsychotic treatment will be recruited. These participants are randomised to treatment with CBD oral solution 500mg twice daily, or a matching placebo for 6 weeks, as an adjunct to their existing antipsychotic treatment. By using a battery of clinical outcome assessments, the trial will also assess several biomarkers to determine if they can be used to predict clinical outcomes and response to treatment with CBD. Biomarkers are being assessed as an exploratory outcome measure. Participants will be invited to provide blood and stool samples, and may be asked to complete neuroimaging assessments at certain eligible sites.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
There is inadequate information on the effects of cannabidiol on the foetus in humans. Participants of childbearing potential* should use a highly effective method of contraception** for the duration of the trial and for 3 months after the last time the trial intervention was used.
*A person is considered of childbearing potential, i.e. fertile, following menarche and until becoming unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
** Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include: 1) combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral; intravaginal; transdermal); 2) progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; implantable); 3) intrauterine device (IUD); 4) intrauterine hormone-releasing system (IUS); 5) bilateral tubal occlusion; 6) vasectomised partner; 7) sexual abstinence (abstinence should only be used as a contraceptive method if it is in line with the participants' usual and preferred lifestyle).
Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not an acceptable method of contraception. The participant agrees to use an acceptable method of contraception* for the duration of the study and for 3 months after any study drug administration, unless surgically sterile or postmenopausal (no menses for 12 months without an alternative medical cause).
The age range for eligibility has been applied as this corresponds to the usual age range for first episode psychosis; individual cases outside of this age range may have a different aetiology and/or prognosis which could impact on the study outcomes.
Exclusion criteria:
Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Adequate doses are provided in Appendix B. **Minor neurological disorders such as migraine, other minor headache disorders, sleep disorders or nerve palsies which are unlikely to affect study outcomes including neuroimaging measures are permitted.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive Cannabidiol (CBD) for 6 weeks.
Drug: CBD 100 mg/mL Oral Solution
Participants in this arm will receive placebo for 6 weeks.
Other: Placebo
Drug page: Cannabidiol
Daily dose 1000mg, taken as 500mg (5ml) b.i.d for 6 weeks. For participants with a weight lower than 50 kg, the dose is to be adjusted to 20 mg/kg/day divided over 2 intakes of 10 mg/kg/day, for a period of 6 weeks
5ml b.i.d for 6 weeks; For participants with a weight lower than 50 kg, the dose is to be adjusted to 20 mg/kg/day divided over 2 intakes of 10 mg/kg/day, for a period of 6 weeks
Change in Positive and Negative Syndrome Scale (PANSS) total score
Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to 6 weeks. The minimum value is 1 and the maximum value is 7 for each item of the scale. 1. A patient meets remission criteria if none of the following items score a 4 or higher: P1, P2, P3, N1, N4, N6, G5 and G9. 2. A patient does not meet remission criteria if one or more of these items score a 4 or higher.
Time frame: 6 weeks
Change in symptoms (sub-scale scores)
Change in scores on the PANSS positive, negative and general symptom subscales from baseline to 6 weeks and 58 weeks (if participants consent to the optional 12 months long-term follow-up period).
Time frame: from baseline to 6 weeks and 58weeks
Symptomatic remission
Symptomatic remission after 6 weeks and 58 weeks (if participants consent to the optional 12 months long-term follow-up period as measured using the PANSS, defined using Andreasen (2005) remission criteria. Andreasen, N. C., Carpenter, W. T., Jr, Kane, J. M., Lasser, R. A., Marder, S. R., \& Weinberger, D. R. (2005). Remission in schizophrenia: proposed criteria and rationale for consensus. The American journal of psychiatry, 162(3), 441-449. https://doi.org/10.1176/appi.ajp.162.3.441
Time frame: 6 weeks and 58weeks
Change in overall clinical impression
Change in overall clinical impression, assessed through Clinical Global Impression of Improvement and Severity (CGI-I/S) scales from baseline to 6 weeks and 58 weeks (if participant consent to the optional 12 months long-term follow-up period).
Time frame: from baseline to 6 weeks and 58weeks
Change in functioning
Change in functioning, assessed through Social and Occupational Function Scale (SOFAS) from baseline to 6 weeks and 58 weeks (if participants consent to the optional 12 months long-term follow-up period). Score range 1-100, the higher score means the better function
Time frame: from baseline to 6 weeks and 58weeks
Change in functioning
Change in functioning, assessed through Functional Remission of General Schizophrenia scale (FROGS) from baseline to 6 weeks and 58 weeks (if participants consent to the optional 12 months long-term follow-up period). Scale range for each item: Do not do=1; Do partially=2; Do a significant part=3; Do almost all the activity=4; Do perfectly =5. The higher score means better functioning.
Time frame: from baseline to 6 weeks and 58weeks
Change in functioning
Change in functioning, assessed through Global Functioning Social and Role scales (GF:S, GF:R) from baseline to 6 weeks and 58 weeks (if participants consent to the optional 12 months long-term follow-up period). Scale range 1-100; 1. Different reference period at follow-ups: time since last visit 2. Rate only at baseline At follow-up, the higher score during past observation period can only be above but not below the current score at the last visit (i.e. if lower, the current score of last visit defines score during past observation (usually last 3 months)). The lowest score during past observation period can only be below but not above the current score at the last visit.
Time frame: from baseline to 6 weeks and 58weeks
Change in cognitive functioning
Change in cognitive functioning as assessed through the PsyCog battery from baseline to 6 weeks. PsyCog comprises four tests that were chosen from the larger CANTAB battery to assess the key cognitive deficits associated with psychosis, including:: * Paired Associates Learning (PAL): key measures including PAL total errors adjusted (score range 0-70; lower is better) and PAL first attempt memory score (score range 0-20; higher is better) * Rapid Visual Information Processing (RVP): key measures including RVP A' (score range 0-1; higher is better) and RVP median response latency(ms) (score range 100-1900; lower is better) * Emotion Recognition Task (ERT): key measures including ERT overall median reaction time (ms) (score range 100-00; lower is better) and ERT total hits (score range 0-48; higher is better) * Spatial Span (SSP): key measures including SSP forward span length (score range 3-9; higher is better) and SSP reserve span length (score range 3-9; higher is better)
Time frame: from baseline to 6 weeks
Change in quality of life
Change in quality of life, assessed using the EQ-5D three-level version (EQ-5D-3L) from baseline to 6 weeks and 58 weeks (if participants consent to the optional 12 months long-term follow-up period). It includes five dimensions-MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems (labelled1-3). The respondent is asked to indicate his / her health state by checking the box against the most appropriate statement in each of the five dimensions. The EQ VAS records the respondent's self-rated health on a vertical VAS where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Time frame: from baseline to 6 weeks and 58weeks
Change in quality of life
Change in quality of life, assessed using the World Health Organization Quality-of-Life Scale (WHOQOL-BREF) from baseline to 6 weeks and 58 weeks (if participants consent to the optional 12 months long-term follow-up period). The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale.
Time frame: from baseline to 6 weeks and 58weeks
Acceptability of CBD treatment
Acceptability of CBD treatment, measured through all-cause discontinuation over 6 weeks
Time frame: 6 weeks
Incidence of adverse events
Incidence of adverse events, measured through Glasgow Antipsychotic Side-effect Scale (GASS) over 6 weeks. Spontaneous adverse event reporting is until 30 days after the study intervention has been discontinued.
Time frame: 6 weeks and 30 days post treatment
Changes in measuring the severity of anxiety and depression symptoms
Measure the severity of anxiety symptoms via Hamilton Anxiety Scale (HAM-A) from baseline to 6weeks. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Time frame: from baseline to 6 weeks
Changes in measuring the severity of anxiety and depression symptoms
Measure the severity of anxiety symptoms via the Overall Anxiety Severity and Impairment Scale (OASIS) from baseline to 6weeks. It consists of five items that measure the frequency and severity of anxiety, as well as level of avoidance, work/school/home interference, and social interference associated with anxiety. Respondents select among five different response options for each item, which are coded 0-4 and summed to obtain a total score. Score range is 0-20. The lower score is better in symptoms.
Time frame: from baseline to 6 weeks
Changes in measuring the depression symptoms
Measure the depression in schizophrenia without overlap with negative symptoms and extrapyramidal symptoms by using the Calgary Depression Scale for schizophrenia (CDSS) from baseline to 6weeks. it includes 9 items in the scale. All ratings of the items are defined according to operational criteria from 0-3. The CDSS depression score is obtained by adding each of the item scores. Score range is 0-27, which is the lower score is better.
Time frame: from baseline to 6 weeks
Changes in biomarkers that occur in relation to symptomatic improvement with adjunctive cannabidiol compared to placebo.
Measure the neuroimaging (Magnetic resonance imaging (MRI)) from baseline to 6 weeks if participant consents to it. The Magnetic resonance imaging (MRI) scan includes: T1 - brain structure T2 FLAIR - brain structure / clinical reporting Neuromelanin sensitive MRI - neuromelanin content of substantial nigra (proxy of dopamine activity) Magnetic Resonance Spectroscopy of the anterior cingulate cortex - metabolites e.g. glutamate Resting state fMRI - bold activation during "rest" or free mind wandering
Time frame: baseline and 6 weeks
Changes in biomarkers that occur in relation to symptomatic improvement with adjunctive cannabidiol compared to placebo.
Measure the microbiome samples from baseline to 6 weeks if participant consents to it. The gut-microbiome (the microorganisms e.g. bacteria, normally found in participant's gut) is likely to be at play in determining whether participant respond or experience side effects from CBD. Two tubes of stool samples to be collected at two time points(baseline and week 6) if participant consent to it.
Time frame: baseline and 6 weeks
Changes in biomarkers that occur in relation to symptomatic improvement with adjunctive cannabidiol compared to placebo.
Measure the blood samples for central lab assessment including (Epi)genetics, proteomics, inflammation, metabolomics, Redox markers from baseline to 6 weeks if participant consents to it.
Time frame: from baseline to 6 weeks
Change in overall patient impression of severity and improvement
Change in overall patient impression, assessed through Patient Global Impression of Improvement and Severity (PGI-I/S) scales from baseline to 6 weeks and 58 weeks (if participant consents to the optional 12 months long-term follow-up period) The Patient Global Impression of Improvement (PGI-I) is a single question asking the patient to rate how their psychotic symptoms is now compared to the previous study visit on a scale of 1. very much better to 7. very much worse. The lower score is better in symptoms' improvement. The Patient Global Impression of Severity (PGI-S) is a single question asking the patient to rate how their psychotic symptoms is now on a scale of 1. not present to 7. very severe. The lower score is better in symptoms.
Time frame: from baseline to 6 weeks and 58weeks
Plan to share: Yes — Please contact the sponsor, who will provide instructions for submitting a data request. All data can be requested, regardless of the location of the requesting party.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data and supporting documents will become available once the primary papers are available in the scientific domain.
Access criteria: These will be provided by the sponsor to the requesting party.
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Feb 2028, 16 months after the start.
Of 26 phase 3 interventional studies under Psychotic Disorders, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 72. This study's planned 16 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 8, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Cannabidiol