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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | New Haven | Connecticut | 06519 | United States | ||
| VA Connecticut Healthcare System |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (4 Weeks) |
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| Washout (2 Weeks) |
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| Second Intervention (4 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo, Then Cannabidiol |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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) |
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Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Systematic Assessment | Subject experienced a worsening in symptoms |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohini Ranganathan | Yale | (203)932-5711 | 2546 | mohini.ranganathan@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2017 | Aug 11, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
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| 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. | 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) |
| West Haven |
| Connecticut |
| 06516 |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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) |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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) |
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| 0 |
| 8 |
| 2 |
| 8 |
| 5 |
| 8 |
| EG001 | 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 | 0 | 10 | 0 | 10 | 6 | 10 |
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| Depressed mood, racing thoughts | Psychiatric disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| ER Visit | Reproductive system and breast disorders | Systematic Assessment | Subject went to ER because of pain from her IUD - was sent home same day and instructed to make an appointment with her OB/GYN |
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| Tension headache | General disorders | Systematic Assessment |
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| Migraine | General disorders | Systematic Assessment |
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| Sedation | General disorders | Systematic Assessment | Subject was in wash out period, not taking the study medication |
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| Scratchy throat and cold symptoms | General disorders | Systematic Assessment |
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| Stye in left eye | Eye disorders | Systematic Assessment |
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| Right shin pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Contact dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment | Occurred after using a new body wash |
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| Increased itchiness of rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Caused by previous condition (COPD) |
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| Increased tiredness | General disorders | Systematic Assessment |
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| Pain in right forearm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Veisalgia | General disorders | Systematic Assessment |
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| Vomitting | Gastrointestinal disorders | Systematic Assessment |
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| High blood pressure/hospitalization | Blood and lymphatic system disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Relapse to PCP, LSD, and opiate use | General disorders | Systematic Assessment |
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| Gastrointestinal discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Rash around tattoo | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sleeplessness | General disorders | Systematic Assessment |
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| Pulled leg muscle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | Systematic Assessment | Nausea/gas |
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| Tingling and numbness on right side to body and face | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Swollen left foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Worsening of symptoms and more negative affect | Psychiatric disorders | Systematic Assessment |
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| Flu | General disorders | Systematic Assessment |
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| Sinusitis | General disorders | Systematic Assessment |
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