SchizophreniaPhase 2CBDNCT02504151

Cannabidiol Treatment in Patients With Early Psychosis

A Phase 2 study testing Cannabidiol in people with Schizophrenia and Schizoaffective Disorder, run by Yale University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder
What is being tested?: Cannabidiol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 2 sitesUnited States
Study dates: 28 Jan 2016to 9 Mar 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female
Primary psychotic disorder
Ages 18-65 (inclusive)

Who cannot join

Current significant medical condition or other comorbidities
Current substance depdendence
Women who are pregnant or breastfeeding

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Connecticut Mental Health Center
New Haven, Connecticut, 06519
VA Connecticut Healthcare System
West Haven, Connecticut, 06516

Other trials in United States

About this study

Cannabidiol (CBD) is a component of herbal cannabis that is present in varying concentrations in cannabis extracts. CBD has been shown to produce central effects including hypnotic, anticonvulsive, anxiolytic and neuroprotective effects.The investigators hypothesize that treatment with CBD will result in: 1) Improvement evidenced by a reduction in scores on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), 2) Improvement evidenced by a reduction in the Clinical Global Impression of Severity scale (CGI); Secondary Hypothesis: 1) Greater improvement in functioning as measured on the "Patient Assessment of Own Functioning Inventory: (PAOFI) and the Quality of Life Scale (QLS) In this 2 period cross over design, subjects will be randomized in a 1:1 ratio to receive either: Order 1: CBD (Period 1) followed by placebo (Period 2) or Order 2: Placebo (Period 1) followed by CBD (Period 2) under double-blind conditions. The 2 study periods will be separated by a washout of at least 2 weeks. During each period subjects will receive study medications (CBD [total 800mg/day] or placebo) for a period of 4 weeks.

Conditions: Schizophrenia, Schizoaffective Disorder
Being tested: Cannabidiol, Placebo
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CannabidiolDrug
Also called CBD
PlaceboDrug

Study groups in NCT02504151
Study group	Role	What they receive
Cannabidiol, then Placebo	Experimental	The subject will receive treatment with cannabidiol (CBD)(800mg/day) for four weeks, followed by a two week washout period, followed by four weeks of placebo. Receives: Drug: Cannabidiol; Drug: Placebo
Placebo, then Cannabidiol	Experimental	The subject will receive placebo for four weeks, followed by a two week washout period, followed by four weeks of treatment with cannabidiol (CBD)(800mg/day). Receives: Drug: Cannabidiol; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Positive and Negative Syndrome Scale (PANSS) Over Time
The Positive and Negative Syndrome Scale is a 30-item scale to assess both the positive and negative symptom symptoms of schizophrenia. The range total score is 30-210. An improvement in symptoms is reflected by a lower score.
Measured: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)
Clinical Global Impression of Severity Scale Over Time
Clinical Global Impression of Severity Scale score is a global rating of improvement scale, which requires subjects to rate their degree of improvement on a 7-point scale. The total range score is 1-7. A reduction in scores indicates improvement.
Measured: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)

Secondary outcomes (2)

Patient Assessment of Own Functioning Inventory (PAOFI) Over Time
The PAOFI measures subjects' perceptions of functioning when performing everyday tasks and activities that reflect cognitive strengths and weaknesses. Subjects rate each item on a scale ranging from 0 (almost never) to 5 (almost always). The total score is the sum of the responses to each item (score of 0 to 160). High scores on the PAOFI subscales are indicative of poor perceived cognitive functioning. This scale was modified to remove 3 items- so the highest possible score is 145 for this outcome measure.
Measured: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)
Quality of Life Scale (QLS) Over Time
The Quality of Life Scale (QLS) is a 21-item scale rated from a semi structured interview, each item is rated 0-6. The specific descriptors vary among items, but the high end of the scales (scores of 5 and 6) reflects normal or unimpaired functioning, and the low end of the scales (scores of 0 and 1) reflects severe impairment of the function in question. A highest score of 126 would indicate unimpaired functioning.
Measured: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jan 20169 Mar 2018

First posted21 Jul 2015 (estimated)
Study start28 Jan 2016
Primary completion2 Mar 2018
Study completion9 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02504151
Sponsor's protocol ID: 1412015000
Acronym: CBD
Status last verified: Aug 2022
First submitted: 17 Jul 2015
Last updated: 6 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cannabidiol Treatment in Patients With Early Psychosis
ClinicalTrials.gov ID: NCT02504151
Acronym / sponsor ID: CBD / 1412015000
Conditions: Schizophrenia, Schizoaffective Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Study start: 28 Jan 2016 (actual)
Primary completion: 2 Mar 2018 (actual)
Study completion: 9 Mar 2018 (actual)
First posted: 21 Jul 2015 (estimated)
Results: Posted 6 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cannabidiol, then Placebo	Experimental	Drug: Cannabidiol, Drug: PlaceboThe subject will receive treatment with cannabidiol (CBD)(800mg/day) for four weeks, followed by a two week washout period, followed by four weeks of placebo.
Placebo, then Cannabidiol	Experimental	Drug: Cannabidiol, Drug: PlaceboThe subject will receive placebo for four weeks, followed by a two week washout period, followed by four weeks of treatment with cannabidiol (CBD)(800mg/day).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female
Primary psychotic disorder
Ages 18-65 (inclusive)

Key exclusion criteria (3 listed)

Current significant medical condition or other comorbidities
Current substance depdendence
Women who are pregnant or breastfeeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CannabidiolAlso: CBD	Drug	Cannabidiol, then Placebo, Placebo, then Cannabidiol
Placebo	Drug	Cannabidiol, then Placebo, Placebo, then Cannabidiol

Primary outcome

Positive and Negative Syndrome Scale (PANSS) Over Time
Time frame: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)
The Positive and Negative Syndrome Scale is a 30-item scale to assess both the positive and negative symptom symptoms of schizophrenia. The range total score is 30-210. An improvement in symptoms is reflected by a lower score.
Clinical Global Impression of Severity Scale Over Time
Time frame: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)
Clinical Global Impression of Severity Scale score is a global rating of improvement scale, which requires subjects to rate their degree of improvement on a 7-point scale. The total range score is 1-7. A reduction in scores indicates improvement.

2 secondary outcomes

Patient Assessment of Own Functioning Inventory (PAOFI) Over Time
Time frame: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)
Quality of Life Scale (QLS) Over Time
Time frame: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)

Results and safety

Results posted to the registry on 6 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cannabidiol, Then Placebo	8	7
Placebo, Then Cannabidiol	10	9

Primary outcome: Positive and Negative Syndrome Scale (PANSS) Over Time

Time frame: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4). Least squares mean (Standard Error). Unit: score on a scale

Measure	Cannabidiol, Then Placebo n = 8	Placebo, Then Cannabidiol n = 10
Baseline period 1	81.3 (2.8)	84.0 (2.3)
Week 1 period 1	78.3 (2.8)	75.3 (2.3)
Week 2 period 1	81.4 (2.8)	73.9 (2.3)
Week 3 period 1	79.6 (2.8)	70.6 (2.4)
Week 4 period 1	72.0 (2.8)	69.0 (2.0)
Baseline period 2	71.9 (3.4)	68.5 (2.4)
Week 1 period 2	75.2 (3.4)	67.6 (2.5)
Week 2 period 2	72.7 (3.4)	70.1 (2.5)

Cannabidiol, Then Placebo vs Placebo, Then Cannabidiol: Mean Difference (Net): -.284 (95% CI -2.28 to 1.71), p = 0.08, Mixed Models Analysis

Population analysed: The number analyzed in one or more rows differ from the overall number analyzed to reflect the number of participants who completed the scale during each time point.

Primary outcome: Clinical Global Impression of Severity Scale Over Time

Measure	Cannabidiol, Then Placebo n = 8	Placebo, Then Cannabidiol n = 10
Baseline period 1	4.1 (0.2)	4.2 (0.2)
Week 1 period 1	4.1 (0.2)	4.2 (0.2)
Week 2 period 1	4.4 (0.2)	4.2 (0.2)
Week 3 period 1	4.4 (0.2)	4.4 (0.2)
Week 4 period 1	4.3 (0.2)	4.4 (0.2)
Baseline period 2	4.3 (0.2)	4.3 (0.2)
Week 1 period 2	4.3 (0.2)	4.0 (0.2)
Week 2 period 2	4.3 (0.2)	4.4 (0.2)

Cannabidiol, Then Placebo vs Placebo, Then Cannabidiol: Mean Difference (Net): -0.03 (95% CI -0.12 to 0.07), p = 0.48, Mixed Models Analysis

Population analysed: The number analyzed in one or more rows differ from the overall number analyzed to reflect the number of participants who completed the scale during each time point.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cannabidiol, Then Placebo	2 of 8 (25%)	5 of 8 (62.5%)	0 of 8
Placebo, Then Cannabidiol	0 of 10 (0%)	6 of 10 (60%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cannabidiol in people with Schizophrenia and Schizoaffective Disorder, run by Yale University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive and Negative Syndrome Scale (PANSS) Over Time (time frame: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02504151.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.