Schizoaffective Disorder, Schizophrenia
Conditions
Brief summary
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.
Interventions
DRUGCannabidiol
DRUGPlacebo
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female * Primary psychotic disorder * Ages 18-65 (inclusive)
Exclusion criteria
* Current significant medical condition or other comorbidities * Current substance depdendence * Women who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cannabidiol, Then Placebo The subject will receive treatment with Cannabidiol (CBD) (800 mg/day) for four weeks, followed by a two week washout period, followed by four weeks of placebo.
Period 1: CBD, 800 mg/day Period 2: Placebo | 8 |
| Placebo, Then Cannabidiol The subject will receive placebo for four weeks, followed by a 2 week washout period, followed by four weeks of treatment with Cannabidiol (CBD) (800 mg/day).
Period 1: Placebo Period 2: CBD, 800 mg/day | 10 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (4 Weeks) | Physician Decision | 1 | 1 |
| Second Intervention (4 Weeks) | Physician Decision | 2 | 1 |
| Second Intervention (4 Weeks) | Withdrawal by Subject | 0 | 1 |
| Washout (2 Weeks) | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Cannabidiol, Then Placebo | Total | Placebo, Then Cannabidiol |
|---|---|---|---|
| Age, Continuous | 22.875 years | 25 years | 26.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 14 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 4 Participants | 3 Participants |
| Region of Enrollment United States | 8 participants | 18 participants | 10 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 6 Participants | 14 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 10 |
| other Total, other adverse events | 5 / 8 | 6 / 10 |
| serious Total, serious adverse events | 2 / 8 | 0 / 10 |
Outcome results
Primary
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.
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)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol, Then Placebo | Clinical Global Impression of Severity Scale Over Time | Baseline period 1 | 4.1 score on a scale | Standard Deviation 0.2 |
| Cannabidiol, Then Placebo | Clinical Global Impression of Severity Scale Over Time | Week 1 period 1 | 4.1 score on a scale | Standard Deviation 0.2 |
| Cannabidiol, Then Placebo | Clinical Global Impression of Severity Scale Over Time | Week 2 period 1 | 4.4 score on a scale | Standard Deviation 0.2 |
| Cannabidiol, Then Placebo | Clinical Global Impression of Severity Scale Over Time | Week 3 period 1 | 4.4 score on a scale | Standard Deviation 0.2 |
| Cannabidiol, Then Placebo | Clinical Global Impression of Severity Scale Over Time | Week 4 period 1 | 4.3 score on a scale | Standard Deviation 0.2 |
| Cannabidiol, Then Placebo | Clinical Global Impression of Severity Scale Over Time | Baseline period 2 | 4.3 score on a scale | Standard Deviation 0.2 |
| Cannabidiol, Then Placebo | Clinical Global Impression of Severity Scale Over Time | Week 1 period 2 | 4.3 score on a scale | Standard Deviation 0.2 |
| Cannabidiol, Then Placebo | Clinical Global Impression of Severity Scale Over Time | Week 2 period 2 | 4.3 score on a scale | Standard Deviation 0.2 |
| Cannabidiol, Then Placebo | Clinical Global Impression of Severity Scale Over Time | Week 3 period 2 | 4.3 score on a scale | Standard Deviation 0.2 |
| Cannabidiol, Then Placebo | Clinical Global Impression of Severity Scale Over Time | Week 4 period 2 | 4.3 score on a scale | Standard Deviation 0.2 |
| Placebo, Then Cannabidiol | Clinical Global Impression of Severity Scale Over Time | Week 2 period 2 | 4.4 score on a scale | Standard Deviation 0.2 |
| Placebo, Then Cannabidiol | Clinical Global Impression of Severity Scale Over Time | Baseline period 1 | 4.2 score on a scale | Standard Deviation 0.2 |
| Placebo, Then Cannabidiol | Clinical Global Impression of Severity Scale Over Time | Baseline period 2 | 4.3 score on a scale | Standard Deviation 0.2 |
| Placebo, Then Cannabidiol | Clinical Global Impression of Severity Scale Over Time | Week 1 period 1 | 4.2 score on a scale | Standard Deviation 0.2 |
| Placebo, Then Cannabidiol | Clinical Global Impression of Severity Scale Over Time | Week 4 period 2 | 4.2 score on a scale | Standard Deviation 0.2 |
| Placebo, Then Cannabidiol | Clinical Global Impression of Severity Scale Over Time | Week 2 period 1 | 4.2 score on a scale | Standard Deviation 0.2 |
| Placebo, Then Cannabidiol | Clinical Global Impression of Severity Scale Over Time | Week 1 period 2 | 4.0 score on a scale | Standard Deviation 0.2 |
| Placebo, Then Cannabidiol | Clinical Global Impression of Severity Scale Over Time | Week 3 period 1 | 4.4 score on a scale | Standard Deviation 0.2 |
| Placebo, Then Cannabidiol | Clinical Global Impression of Severity Scale Over Time | Week 3 period 2 | 4.2 score on a scale | Standard Deviation 0.2 |
| Placebo, Then Cannabidiol | Clinical Global Impression of Severity Scale Over Time | Week 4 period 1 | 4.4 score on a scale | Standard Deviation 0.2 |
Comparison: The p value is based on the interaction of treatment and time.p-value: 0.4895% CI: [-0.12, 0.07]Mixed Models Analysis
Primary
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.
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)
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol, Then Placebo | Positive and Negative Syndrome Scale (PANSS) Over Time | Baseline period 1 | 81.3 score on a scale | Standard Error 2.8 |
| Cannabidiol, Then Placebo | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 1 period 1 | 78.3 score on a scale | Standard Error 2.8 |
| Cannabidiol, Then Placebo | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 2 period 1 | 81.4 score on a scale | Standard Error 2.8 |
| Cannabidiol, Then Placebo | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 3 period 1 | 79.6 score on a scale | Standard Error 2.8 |
| Cannabidiol, Then Placebo | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 4 period 1 | 72.0 score on a scale | Standard Error 2.8 |
| Cannabidiol, Then Placebo | Positive and Negative Syndrome Scale (PANSS) Over Time | Baseline period 2 | 71.9 score on a scale | Standard Error 3.4 |
| Cannabidiol, Then Placebo | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 1 period 2 | 75.2 score on a scale | Standard Error 3.4 |
| Cannabidiol, Then Placebo | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 2 period 2 | 72.7 score on a scale | Standard Error 3.4 |
| Cannabidiol, Then Placebo | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 3 period 2 | 73.2 score on a scale | Standard Error 3.4 |
| Cannabidiol, Then Placebo | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 4 period 2 | 72.4 score on a scale | Standard Error 3.4 |
| Placebo, Then Cannabidiol | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 2 period 2 | 70.1 score on a scale | Standard Error 2.5 |
| Placebo, Then Cannabidiol | Positive and Negative Syndrome Scale (PANSS) Over Time | Baseline period 1 | 84.0 score on a scale | Standard Error 2.3 |
| Placebo, Then Cannabidiol | Positive and Negative Syndrome Scale (PANSS) Over Time | Baseline period 2 | 68.5 score on a scale | Standard Error 2.4 |
| Placebo, Then Cannabidiol | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 1 period 1 | 75.3 score on a scale | Standard Error 2.3 |
| Placebo, Then Cannabidiol | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 4 period 2 | 66.9 score on a scale | Standard Error 2.6 |
| Placebo, Then Cannabidiol | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 2 period 1 | 73.9 score on a scale | Standard Error 2.3 |
| Placebo, Then Cannabidiol | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 1 period 2 | 67.6 score on a scale | Standard Error 2.5 |
| Placebo, Then Cannabidiol | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 3 period 1 | 70.6 score on a scale | Standard Error 2.4 |
| Placebo, Then Cannabidiol | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 3 period 2 | 69.7 score on a scale | Standard Error 2.6 |
| Placebo, Then Cannabidiol | Positive and Negative Syndrome Scale (PANSS) Over Time | Week 4 period 1 | 69.0 score on a scale | Standard Error 2 |
Comparison: The p value is based on the interaction of treatment and time.p-value: 0.0895% CI: [-2.28, 1.71]Mixed Models Analysis
Secondary
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.
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)
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol, Then Placebo | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Baseline period 1 | 90.1 score on a scale | Standard Error 11.3 |
| Cannabidiol, Then Placebo | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 1 period 1 | 85.3 score on a scale | Standard Error 11.3 |
| Cannabidiol, Then Placebo | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 2 period 1 | 95.3 score on a scale | Standard Error 11.3 |
| Cannabidiol, Then Placebo | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 3 period 1 | 93.0 score on a scale | Standard Error 11.3 |
| Cannabidiol, Then Placebo | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 4 period 1 | 95.6 score on a scale | Standard Error 11.3 |
| Cannabidiol, Then Placebo | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Baseline period 2 | 105.4 score on a scale | Standard Error 12.2 |
| Cannabidiol, Then Placebo | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 1 period 2 | 108.4 score on a scale | Standard Error 12.2 |
| Cannabidiol, Then Placebo | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 2 period 2 | 104.7 score on a scale | Standard Error 12.2 |
| Cannabidiol, Then Placebo | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 3 period 2 | 105.2 score on a scale | Standard Error 12.2 |
| Cannabidiol, Then Placebo | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 4 period 2 | 107.2 score on a scale | Standard Error 12.2 |
| Placebo, Then Cannabidiol | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 2 period 2 | 90.7 score on a scale | Standard Error 9.7 |
| Placebo, Then Cannabidiol | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Baseline period 1 | 85.1 score on a scale | Standard Error 9.4 |
| Placebo, Then Cannabidiol | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Baseline period 2 | 87.3 score on a scale | Standard Error 9.6 |
| Placebo, Then Cannabidiol | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 1 period 1 | 87.5 score on a scale | Standard Error 9.4 |
| Placebo, Then Cannabidiol | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 4 period 2 | 95.6 score on a scale | Standard Error 9.9 |
| Placebo, Then Cannabidiol | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 2 period 1 | 74.9 score on a scale | Standard Error 9.4 |
| Placebo, Then Cannabidiol | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 1 period 2 | 88.5 score on a scale | Standard Error 9.7 |
| Placebo, Then Cannabidiol | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 3 period 1 | 89.9 score on a scale | Standard Error 9.4 |
| Placebo, Then Cannabidiol | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 3 period 2 | 86.3 score on a scale | Standard Error 9.9 |
| Placebo, Then Cannabidiol | Patient Assessment of Own Functioning Inventory (PAOFI) Over Time | Week 4 period 1 | 89.0 score on a scale | Standard Error 9.6 |
Comparison: The p value is based on the interaction of treatment and time.p-value: 0.48595% CI: [-9.87, -0.06]Mixed Models Analysis
Secondary
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.
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)
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol, Then Placebo | Quality of Life Scale (QLS) Over Time | Baseline period 1 | 70.4 score on a scale | Standard Error 7.7 |
| Cannabidiol, Then Placebo | Quality of Life Scale (QLS) Over Time | Week 1 period 1 | 73.4 score on a scale | Standard Error 7.7 |
| Cannabidiol, Then Placebo | Quality of Life Scale (QLS) Over Time | Week 2 period 1 | 69.9 score on a scale | Standard Error 7.7 |
| Cannabidiol, Then Placebo | Quality of Life Scale (QLS) Over Time | Week 3 period 1 | 69.0 score on a scale | Standard Error 7.7 |
| Cannabidiol, Then Placebo | Quality of Life Scale (QLS) Over Time | Week 4 period 1 | 72.3 score on a scale | Standard Error 7.7 |
| Cannabidiol, Then Placebo | Quality of Life Scale (QLS) Over Time | Baseline period 2 | 68.6 score on a scale | Standard Error 8.6 |
| Cannabidiol, Then Placebo | Quality of Life Scale (QLS) Over Time | Week 1 period 2 | 68.6 score on a scale | Standard Error 8.6 |
| Cannabidiol, Then Placebo | Quality of Life Scale (QLS) Over Time | Week 2 period 2 | 70.1 score on a scale | Standard Error 8.6 |
| Cannabidiol, Then Placebo | Quality of Life Scale (QLS) Over Time | Week 3 period 2 | 66.3 score on a scale | Standard Error 8.6 |
| Cannabidiol, Then Placebo | Quality of Life Scale (QLS) Over Time | Week 4 period 2 | 71.8 score on a scale | Standard Error 8.6 |
| Placebo, Then Cannabidiol | Quality of Life Scale (QLS) Over Time | Week 2 period 2 | 77.6 score on a scale | Standard Error 6.7 |
| Placebo, Then Cannabidiol | Quality of Life Scale (QLS) Over Time | Baseline period 1 | 72.9 score on a scale | Standard Error 6.4 |
| Placebo, Then Cannabidiol | Quality of Life Scale (QLS) Over Time | Baseline period 2 | 73.3 score on a scale | Standard Error 6.5 |
| Placebo, Then Cannabidiol | Quality of Life Scale (QLS) Over Time | Week 1 period 1 | 74.9 score on a scale | Standard Error 6.4 |
| Placebo, Then Cannabidiol | Quality of Life Scale (QLS) Over Time | Week 4 period 2 | 82.7 score on a scale | Standard Error 6.8 |
| Placebo, Then Cannabidiol | Quality of Life Scale (QLS) Over Time | Week 2 period 1 | 67.1 score on a scale | Standard Error 6.4 |
| Placebo, Then Cannabidiol | Quality of Life Scale (QLS) Over Time | Week 1 period 2 | 76.7 score on a scale | Standard Error 6.7 |
| Placebo, Then Cannabidiol | Quality of Life Scale (QLS) Over Time | Week 3 period 1 | 71.1 score on a scale | Standard Error 6.4 |
| Placebo, Then Cannabidiol | Quality of Life Scale (QLS) Over Time | Week 3 period 2 | 78.1 score on a scale | Standard Error 6.8 |
| Placebo, Then Cannabidiol | Quality of Life Scale (QLS) Over Time | Week 4 period 1 | 70.7 score on a scale | Standard Error 6.5 |
Comparison: The p value is based on the interaction of treatment and time.p-value: 0.99495% CI: [0.07, 8.19]Mixed Models Analysis