Trial Outcomes & Findings for Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia (NCT NCT00588731)
NCT ID: NCT00588731
Last Updated: 2017-06-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
6 weeks
Results posted on
2017-06-08
Participant Flow
Participant milestones
| Measure |
Cannabidiol
Cannabidiol: Active Cannabidiol daily over 6 weeks
|
Placebo
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Cannabidiol
Cannabidiol: Active Cannabidiol daily over 6 weeks
|
Placebo
Placebo: Placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia
Baseline characteristics by cohort
| Measure |
Cannabidiol
n=18 Participants
Cannabidiol: Active Cannabidiol daily over 6 weeks
|
Placebo
n=18 Participants
Placebo: Placebo
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
47.4 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Length of Diagnosis
|
25.6 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
28.2 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
26.9 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Intelligence Quotient (IQ)
|
91.6 IQ
STANDARD_DEVIATION 18.4 • n=5 Participants
|
82.3 IQ
STANDARD_DEVIATION 15.4 • n=7 Participants
|
86.6 IQ
STANDARD_DEVIATION 17.3 • n=5 Participants
|
|
Education
|
13.2 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
12.8 years
STANDARD_DEVIATION 2 • n=7 Participants
|
13 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Smoking Status
Smokers
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Smoking Status
Non-Smokers
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Hopkins Verbal Learning Test T-Score
|
32.5 T-Score
STANDARD_DEVIATION 6.3 • n=5 Participants
|
34.5 T-Score
STANDARD_DEVIATION 6 • n=7 Participants
|
33.5 T-Score
STANDARD_DEVIATION 6.15 • n=5 Participants
|
|
Positive And Negative Syndrome Scale
PANSS Total Score
|
76.6 T-score
STANDARD_DEVIATION 17 • n=5 Participants
|
82.7 T-score
STANDARD_DEVIATION 8.8 • n=7 Participants
|
79.65 T-score
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Positive And Negative Syndrome Scale
PANSS Positive Subscale
|
18.8 T-score
STANDARD_DEVIATION 4.7 • n=5 Participants
|
20.6 T-score
STANDARD_DEVIATION 3.8 • n=7 Participants
|
19.7 T-score
STANDARD_DEVIATION 4.25 • n=5 Participants
|
|
Positive And Negative Syndrome Scale
PANSS Negative Subscale
|
20.7 T-score
STANDARD_DEVIATION 4.6 • n=5 Participants
|
20.9 T-score
STANDARD_DEVIATION 4.7 • n=7 Participants
|
20.8 T-score
STANDARD_DEVIATION 4.65 • n=5 Participants
|
|
Positive And Negative Syndrome Scale
PANSS General Subscale
|
37.1 T-score
STANDARD_DEVIATION 10.3 • n=5 Participants
|
41.2 T-score
STANDARD_DEVIATION 5.6 • n=7 Participants
|
39.15 T-score
STANDARD_DEVIATION 7.95 • n=5 Participants
|
|
Medications
First Generation Antipsychotics
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Medications
Second Generation Antipsychotics
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Medications
Multiple Antipsychotics
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Medications
Long Acting Injectable Antipsychotics
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Medications
Antidepressant
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Medications
Anticholinergic
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Medications
Anticonvulsants/Mood Stabilizers
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Medications
Benzodiazepine
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksVerbal 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.
Outcome measures
| Measure |
Cannabidiol
n=18 Participants
Cannabidiol: Active Cannabidiol daily over 6 weeks
|
Placebo
n=18 Participants
Placebo: Placebo
|
|---|---|---|
|
Verbal Short Term Memory
Baseline
|
43.7 t-score
Standard Deviation 9.7
|
37.9 t-score
Standard Deviation 7.4
|
|
Verbal Short Term Memory
Endpoint
|
43.6 t-score
Standard Deviation 10.8
|
40.8 t-score
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 6 weeksMeasurement 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.
Outcome measures
| Measure |
Cannabidiol
n=18 Participants
Cannabidiol: Active Cannabidiol daily over 6 weeks
|
Placebo
n=18 Participants
Placebo: Placebo
|
|---|---|---|
|
Overall Cognition as Measured on the MATRICS Battery
Baseline
|
27.8 t-score
Standard Deviation 14
|
23.2 t-score
Standard Deviation 13.3
|
|
Overall Cognition as Measured on the MATRICS Battery
Endpoint
|
26.4 t-score
Standard Deviation 12.2
|
25.4 t-score
Standard Deviation 12.5
|
Adverse Events
Cannabidiol
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cannabidiol
n=21 participants at risk
Cannabidiol: Active Cannabidiol daily over 6 weeks
|
Placebo
n=20 participants at risk
Placebo: Placebo
|
|---|---|---|
|
Social circumstances
Social Stress
|
0.00%
0/21
|
5.0%
1/20
|
|
Psychiatric disorders
Anxiety
|
4.8%
1/21
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
Appetite Changes
|
4.8%
1/21
|
5.0%
1/20
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21
|
20.0%
4/20
|
|
Psychiatric disorders
Abnormal Dreams
|
4.8%
1/21
|
10.0%
2/20
|
|
Gastrointestinal disorders
Dry Mouth
|
14.3%
3/21
|
10.0%
2/20
|
|
Endocrine disorders
Endocrine
|
4.8%
1/21
|
5.0%
1/20
|
|
Nervous system disorders
Extrapyramidal Side Effects
|
4.8%
1/21
|
0.00%
0/20
|
|
Psychiatric disorders
Feeling "High"
|
4.8%
1/21
|
0.00%
0/20
|
|
Gastrointestinal disorders
Gastrointestinal
|
28.6%
6/21
|
50.0%
10/20
|
|
Infections and infestations
Infection
|
19.0%
4/21
|
20.0%
4/20
|
|
Nervous system disorders
Pain
|
33.3%
7/21
|
35.0%
7/20
|
|
Eye disorders
Photosensitivity
|
0.00%
0/21
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
1/21
|
0.00%
0/20
|
|
Gastrointestinal disorders
Salivation
|
0.00%
0/21
|
5.0%
1/20
|
|
Nervous system disorders
Sedation
|
19.0%
4/21
|
5.0%
1/20
|
|
Reproductive system and breast disorders
Sexual Side Effects
|
4.8%
1/21
|
10.0%
2/20
|
|
Nervous system disorders
Sleep
|
9.5%
2/21
|
25.0%
5/20
|
|
Gastrointestinal disorders
Taste
|
0.00%
0/21
|
5.0%
1/20
|
|
Psychiatric disorders
Tension
|
0.00%
0/21
|
5.0%
1/20
|
|
Psychiatric disorders
Visual Changes
|
0.00%
0/21
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
Weight Change
|
0.00%
0/21
|
5.0%
1/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place