Schizoaffective Disorder, Schizophrenia
Conditions
Brief summary
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.
Interventions
DRUGCannabidiol
Active Cannabidiol daily over 6 weeks
DRUGPlacebo
Placebo
Sponsors
Stanley Medical Research Institute
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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
* Schizophrenia or Schizoaffective disorder (DSM-IV SCID-confirmed),
Exclusion criteria
* Women who are pregnant, nursing or unwilling to use appropriate birth control measures during study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Short Term Memory | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Cognition as Measured on the MATRICS Battery | 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cannabidiol Cannabidiol: Active Cannabidiol daily over 6 weeks | 18 |
| Placebo Placebo: Placebo | 18 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | Cannabidiol |
|---|---|---|---|
| Age, Continuous | 46.4 years STANDARD_DEVIATION 9.5 | 47.4 years STANDARD_DEVIATION 9.3 | 48.4 years STANDARD_DEVIATION 9.3 |
| Education | 12.8 years STANDARD_DEVIATION 2 | 13 years STANDARD_DEVIATION 1.8 | 13.2 years STANDARD_DEVIATION 1.6 |
| Hopkins Verbal Learning Test T-Score | 34.5 T-Score STANDARD_DEVIATION 6 | 33.5 T-Score STANDARD_DEVIATION 6.15 | 32.5 T-Score STANDARD_DEVIATION 6.3 |
| Intelligence Quotient (IQ) | 82.3 IQ STANDARD_DEVIATION 15.4 | 86.6 IQ STANDARD_DEVIATION 17.3 | 91.6 IQ STANDARD_DEVIATION 18.4 |
| Length of Diagnosis | 28.2 years STANDARD_DEVIATION 8.5 | 26.9 years STANDARD_DEVIATION 10.6 | 25.6 years STANDARD_DEVIATION 12.7 |
| Medications Anticholinergic | 7 participants | 14 participants | 7 participants |
| Medications Anticonvulsants/Mood Stabilizers | 6 participants | 9 participants | 3 participants |
| Medications Antidepressant | 4 participants | 7 participants | 3 participants |
| Medications Benzodiazepine | 3 participants | 5 participants | 2 participants |
| Medications First Generation Antipsychotics | 5 participants | 14 participants | 9 participants |
| Medications Long Acting Injectable Antipsychotics | 6 participants | 9 participants | 3 participants |
| Medications Multiple Antipsychotics | 7 participants | 9 participants | 2 participants |
| Medications Second Generation Antipsychotics | 13 participants | 23 participants | 10 participants |
| Positive And Negative Syndrome Scale PANSS General Subscale | 41.2 T-score STANDARD_DEVIATION 5.6 | 39.15 T-score STANDARD_DEVIATION 7.95 | 37.1 T-score STANDARD_DEVIATION 10.3 |
| Positive And Negative Syndrome Scale PANSS Negative Subscale | 20.9 T-score STANDARD_DEVIATION 4.7 | 20.8 T-score STANDARD_DEVIATION 4.65 | 20.7 T-score STANDARD_DEVIATION 4.6 |
| Positive And Negative Syndrome Scale PANSS Positive Subscale | 20.6 T-score STANDARD_DEVIATION 3.8 | 19.7 T-score STANDARD_DEVIATION 4.25 | 18.8 T-score STANDARD_DEVIATION 4.7 |
| Positive And Negative Syndrome Scale PANSS Total Score | 82.7 T-score STANDARD_DEVIATION 8.8 | 79.65 T-score STANDARD_DEVIATION 12.9 | 76.6 T-score STANDARD_DEVIATION 17 |
| 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 | 12 Participants | 19 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 15 Participants | 10 Participants |
| Region of Enrollment United States | 18 participants | 36 participants | 18 participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Male | 13 Participants | 25 Participants | 12 Participants |
| Smoking Status Non-Smokers | 8 participants | 17 participants | 9 participants |
| Smoking Status Smokers | 10 participants | 19 participants | 9 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 21 | 17 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
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.
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol | Verbal Short Term Memory | Baseline | 43.7 t-score | Standard Deviation 9.7 |
| Cannabidiol | Verbal Short Term Memory | Endpoint | 43.6 t-score | Standard Deviation 10.8 |
| Placebo | Verbal Short Term Memory | Baseline | 37.9 t-score | Standard Deviation 7.4 |
| Placebo | Verbal Short Term Memory | Endpoint | 40.8 t-score | Standard Deviation 8.5 |
p-value: 0.9ANOVA
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.
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol | Overall Cognition as Measured on the MATRICS Battery | Baseline | 27.8 t-score | Standard Deviation 14 |
| Cannabidiol | Overall Cognition as Measured on the MATRICS Battery | Endpoint | 26.4 t-score | Standard Deviation 12.2 |
| Placebo | Overall Cognition as Measured on the MATRICS Battery | Baseline | 23.2 t-score | Standard Deviation 13.3 |
| Placebo | Overall Cognition as Measured on the MATRICS Battery | Endpoint | 25.4 t-score | Standard Deviation 12.5 |
p-value: 0.76ANOVA