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| ID | Type | Description | Link |
|---|---|---|---|
| 07TGS-1082 |
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| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
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This study is a six-week, randomized, placebo-controlled, fixed dose trial comparing cannabidiol Vs. placebo added to a stable dose of antipsychotic medications in patients diagnosed with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | Active Cannabidiol daily over 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Short Term Memory | Verbal short term memory is measured through the Hopkins Verbal Learning Test. Each trial has a max total score of 12 (range of 0-12), and the max total score for all three trials is 36 (range of 0-36). However, the data listed below is reported in the form of a t-score, with a higher score representing better verbal learning. These t-score values are normalizing the scores to populations, comparing them to a representative sample, with a mean of 50. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Cognition as Measured on the MATRICS Battery | Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) is intended to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. A higher score indicates better cognition (i.e. speed of processing, attention, verbal and non-verbal working memory, visual learning, reasoning, problem solving, and social cognition). The below scores are t-score values, which are normalized scores to the population and comparing the scores to a representative sample. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohini Ranganathan, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29619533 | Derived | Boggs DL, Surti T, Gupta A, Gupta S, Niciu M, Pittman B, Schnakenberg Martin AM, Thurnauer H, Davies A, D'Souza DC, Ranganathan M. The effects of cannabidiol (CBD) on cognition and symptoms in outpatients with chronic schizophrenia a randomized placebo controlled trial. Psychopharmacology (Berl). 2018 Jul;235(7):1923-1932. doi: 10.1007/s00213-018-4885-9. Epub 2018 Apr 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cannabidiol | Cannabidiol: Active Cannabidiol daily over 6 weeks |
| FG001 | Placebo | Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 36 participants completed all aspects of the study. Higher T-scores represent better outcomes.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cannabidiol | Cannabidiol: Active Cannabidiol daily over 6 weeks |
| BG001 | Placebo | Placebo: Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Verbal Short Term Memory | Verbal short term memory is measured through the Hopkins Verbal Learning Test. Each trial has a max total score of 12 (range of 0-12), and the max total score for all three trials is 36 (range of 0-36). However, the data listed below is reported in the form of a t-score, with a higher score representing better verbal learning. These t-score values are normalizing the scores to populations, comparing them to a representative sample, with a mean of 50. | Posted | Mean | Standard Deviation | t-score | 6 weeks |
|
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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 | Cannabidiol: Active Cannabidiol daily over 6 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Social Stress | Social circumstances | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohini Ranganathan, M.D. | Yale University | 203-932-5711 | 2546 | mohini.ranganathan@yale.edu |
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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 |
Placebo |
|
| 6 weeks |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Length of Diagnosis | Mean | Standard Deviation | years |
|
| Intelligence Quotient (IQ) | Mean | Standard Deviation | IQ |
|
| Education | Mean | Standard Deviation | years |
|
| Smoking Status | Number | participants |
|
| Hopkins Verbal Learning Test T-Score | The Hopkins Verbal Learning Test is a measure of verbal short term memory. Each trial has a max total score of 12 (range of 0-12), and the max total score for all three trials is 36 (range of 0-36). The data listed is reported in the form of a t-score, with a higher score representing better verbal learning. These t-score values are normalizing the scores to populations, comparing them to a representative sample. | Mean | Standard Deviation | T-Score |
|
| Positive And Negative Syndrome Scale | The PANSS is a scale used for measuring symptoms severity of patients with schizophrenia. Of the 30 items included: 7 constitute a Positive Scale, 7 a Negative Scale, and 16 a General Psychopathology Scale. The scores for these scales are arrived at by summation of ratings across component items (each item scored between 1-7). Therefore, the potential ranges are 7-49 for the Positive and Negative Scales, and 16-112 for the General Psychopathology Scale. The PANSS Total Score is the summation of these subscales and can range from a score of 30-210. A higher score indicates more severe symptoms. | Mean | Standard Deviation | T-score |
|
| Medications | Number | participants |
|
|
|
|
| Secondary | Overall Cognition as Measured on the MATRICS Battery | Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) is intended to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. A higher score indicates better cognition (i.e. speed of processing, attention, verbal and non-verbal working memory, visual learning, reasoning, problem solving, and social cognition). The below scores are t-score values, which are normalized scores to the population and comparing the scores to a representative sample. | Posted | Mean | Standard Deviation | t-score | 6 weeks |
|
|
|
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| 0 |
| 21 |
| 15 |
| 21 |
| EG001 | Placebo | Placebo: Placebo | 0 | 20 | 17 | 20 |
| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Appetite Changes | Metabolism and nutrition disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Abnormal Dreams | Psychiatric disorders | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Endocrine | Endocrine disorders | Systematic Assessment |
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| Extrapyramidal Side Effects | Nervous system disorders | Systematic Assessment |
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| Feeling "High" | Psychiatric disorders | Systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Pain | Nervous system disorders | Systematic Assessment |
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| Photosensitivity | Eye disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Salivation | Gastrointestinal disorders | Systematic Assessment |
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| Sedation | Nervous system disorders | Systematic Assessment |
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| Sexual Side Effects | Reproductive system and breast disorders | Systematic Assessment |
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| Sleep | Nervous system disorders | Systematic Assessment |
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| Taste | Gastrointestinal disorders | Systematic Assessment |
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| Tension | Psychiatric disorders | Systematic Assessment |
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| Visual Changes | Psychiatric disorders | Systematic Assessment |
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| Weight Change | Metabolism and nutrition disorders | Systematic Assessment |
|
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