Trial · NCT02504151
Cannabidiol Treatment in Patients With Early Psychosis
NCT02504151, Phase 2, Completed, Yale University; results first posted 2022-09-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cannabidiol Treatment in Patients With Early Psychosis. Trials, record NCT02504151. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02504151
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cannabidiol Treatment in Patients With Early Psychosis
- NCT number
- NCT02504151
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Interventions
- Cannabidiol, Placebo
- First posted
- 2015-07-21
- Last updated
- 2022-09-06
- Results first posted
- 2022-09-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Positive and Negative Syndrome Scale (PANSS) Over Time | 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. |
| Primary | Clinical Global Impression of Severity Scale Over Time | 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. |
| Secondary | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | 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 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. |
| Secondary | Quality of Life Scale (QLS) Over Time | 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 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Positive and Negative Syndrome Scale (PANSS) Over Time | 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 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. | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Clinical Global Impression of Severity Scale Over Time | 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 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. | score on a scale | MEAN |
| SECONDARY | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | 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 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Quality of Life Scale (QLS) Over Time | 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 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. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) Over Time | Cannabidiol, Then Placebo | Baseline period 1 | 81.3 | Standard Error 2.8 | score on a scale |
| Positive and Negative Syndrome Scale (PANSS) Over Time | Placebo, Then Cannabidiol | Baseline period 1 | 84.0 | Standard Error 2.3 | score on a scale |
| Positive and Negative Syndrome Scale (PANSS) Over Time | Cannabidiol, Then Placebo | Week 1 period 1 | 78.3 | Standard Error 2.8 | score on a scale |
| Positive and Negative Syndrome Scale (PANSS) Over Time | Placebo, Then Cannabidiol | Week 1 period 1 | 75.3 | Standard Error 2.3 | score on a scale |
| Positive and Negative Syndrome Scale (PANSS) Over Time | Cannabidiol, Then Placebo | Week 2 period 1 | 81.4 | Standard Error 2.8 | score on a scale |
| Positive and Negative Syndrome Scale (PANSS) Over Time | Placebo, Then Cannabidiol | Week 2 period 1 | 73.9 | Standard Error 2.3 | score on a scale |
| Positive and Negative Syndrome Scale (PANSS) Over Time | Cannabidiol, Then Placebo | Week 3 period 1 | 79.6 | Standard Error 2.8 | score on a scale |
| Positive and Negative Syndrome Scale (PANSS) Over Time | Placebo, Then Cannabidiol | Week 3 period 1 | 70.6 | Standard Error 2.4 | score on a scale |
| Positive and Negative Syndrome Scale (PANSS) Over Time | Cannabidiol, Then Placebo | Week 4 period 1 | 72.0 | Standard Error 2.8 | score on a scale |
| Positive and Negative Syndrome Scale (PANSS) Over Time | Placebo, Then Cannabidiol | Week 4 period 1 | 69.0 | Standard Error 2.0 | score on a scale |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (4 Weeks) | STARTED | Cannabidiol, Then Placebo | 8 | |
| First Intervention (4 Weeks) | STARTED | Placebo, Then Cannabidiol | 10 | |
| First Intervention (4 Weeks) | COMPLETED | Cannabidiol, Then Placebo | 7 | |
| First Intervention (4 Weeks) | COMPLETED | Placebo, Then Cannabidiol | 9 | |
| First Intervention (4 Weeks) | NOT COMPLETED | Cannabidiol, Then Placebo | 1 | |
| First Intervention (4 Weeks) | NOT COMPLETED | Placebo, Then Cannabidiol | 1 | |
| Washout (2 Weeks) | STARTED | Cannabidiol, Then Placebo | 7 | |
| Washout (2 Weeks) | STARTED | Placebo, Then Cannabidiol | 9 | |
| Washout (2 Weeks) | COMPLETED | Cannabidiol, Then Placebo | 6 | |
| Washout (2 Weeks) | COMPLETED | Placebo, Then Cannabidiol | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events62
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | General disorders | Cannabidiol, Then Placebo | 1 | 8 | 1 |
| other | Dry mouth | General disorders | Placebo, Then Cannabidiol | 2 | 10 | 2 |
| other | Depressed mood, racing thoughts | Psychiatric disorders | Cannabidiol, Then Placebo | 1 | 8 | 1 |
| other | Depressed mood, racing thoughts | Psychiatric disorders | Placebo, Then Cannabidiol | 0 | 10 | 0 |
| other | Nausea | Gastrointestinal disorders | Cannabidiol, Then Placebo | 1 | 8 | 2 |
| other | Nausea | Gastrointestinal disorders | Placebo, Then Cannabidiol | 0 | 10 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Cannabidiol, Then Placebo | 1 | 8 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Placebo, Then Cannabidiol | 1 | 10 | 1 |
| other | ER Visit | Reproductive system and breast disorders | Cannabidiol, Then Placebo | 1 | 8 | 1 |
| other | ER Visit | Reproductive system and breast disorders | Placebo, Then Cannabidiol | 0 | 10 | 0 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cannabidiol, Then Placebo | 0 | 8 |
| Total, all-cause mortality | Placebo, Then Cannabidiol | 0 | 10 |
| Total, other adverse events | Cannabidiol, Then Placebo | 5 | 8 |
| Total, other adverse events | Placebo, Then Cannabidiol | 6 | 10 |
| Total, serious adverse events | Cannabidiol, Then Placebo | 2 | 8 |
| Total, serious adverse events | Placebo, Then Cannabidiol | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cannabidiol, Then Placebo vs Placebo, Then Cannabidiol: deaths from any cause | Trial comparisons |
| Cannabidiol, Then Placebo vs Placebo, Then Cannabidiol: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02504151
GET https://conductscience.org/api/trials/v1/NCT02504151/results?page=2