Trial Outcomes & Findings for Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia (NCT NCT02104752)
NCT ID: NCT02104752
Last Updated: 2019-05-15
Results Overview
This battery was developed as part of the National Institute of Mental Health (NIMH) sponsored Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Initiative to assess cognition in clinical trials of cognition enhancing drugs. The MCCB comprises 10 tests that assess 7 cognitive domains (speed of processing, verbal memory, visual memory, working memory, reasoning and problem solving, attention/vigilance, and social cognition). The MCCB takes approximately 65 minutes to administer and provides age and gender-corrected normed T-scores, including a global composite score and cognitive domain scores. The range of T-scores is between 0 to 100 with a mean of 50. Higher scores indicate better overall cognitive functioning.
COMPLETED
PHASE1/PHASE2
39 participants
Baseline, Week 4, Week 8
2019-05-15
Participant Flow
Participant milestones
| Measure |
Curcumin
Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).
Curcumin: 360 mg/day (divided into twice daily oral doses)
|
Sugar Pill
Matched placebo, 2 capsules twice daily.
Placebo: Inactive, matched placebo ("Sugar Pill")
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
21
|
|
Overall Study
COMPLETED
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Curcumin
Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).
Curcumin: 360 mg/day (divided into twice daily oral doses)
|
Sugar Pill
Matched placebo, 2 capsules twice daily.
Placebo: Inactive, matched placebo ("Sugar Pill")
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Weight gain; unrelated anxiety
|
0
|
2
|
Baseline Characteristics
Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia
Baseline characteristics by cohort
| Measure |
Curcumin
n=17 Participants
Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).
Curcumin: 360 mg/day (divided into twice daily oral doses)
|
Sugar Pill
n=19 Participants
Matched placebo, 2 capsules twice daily.
Placebo: Inactive, matched placebo ("Sugar Pill")
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
50.9 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
50.5 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8This battery was developed as part of the National Institute of Mental Health (NIMH) sponsored Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Initiative to assess cognition in clinical trials of cognition enhancing drugs. The MCCB comprises 10 tests that assess 7 cognitive domains (speed of processing, verbal memory, visual memory, working memory, reasoning and problem solving, attention/vigilance, and social cognition). The MCCB takes approximately 65 minutes to administer and provides age and gender-corrected normed T-scores, including a global composite score and cognitive domain scores. The range of T-scores is between 0 to 100 with a mean of 50. Higher scores indicate better overall cognitive functioning.
Outcome measures
| Measure |
Curcumin
n=17 Participants
Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).
Curcumin: 360 mg/day (divided into twice daily oral doses)
|
Sugar Pill
n=19 Participants
Matched placebo, 2 capsules twice daily.
Placebo: Inactive, matched placebo ("Sugar Pill")
|
|---|---|---|
|
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Baseline
|
36.6 Score on a Scale
Standard Deviation 15.1
|
32.9 Score on a Scale
Standard Deviation 10.3
|
|
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Week 4
|
36.3 Score on a Scale
Standard Deviation 14.5
|
33.8 Score on a Scale
Standard Deviation 11.0
|
|
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Week 8
|
35.8 Score on a Scale
Standard Deviation 14.5
|
33.9 Score on a Scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8A passive attention auditory oddball paradigm will be used to assess MMN. For MMN, difference waves generated by subtracting the standard from deviant event related potentials (ERP) will be analyzed. The specific electrodes used to examine each component will be chosen based on maximal activity seen by inspection of the topographical maps. More negative values indicate a larger (i.e., better) MMN response.
Outcome measures
| Measure |
Curcumin
n=17 Participants
Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).
Curcumin: 360 mg/day (divided into twice daily oral doses)
|
Sugar Pill
n=19 Participants
Matched placebo, 2 capsules twice daily.
Placebo: Inactive, matched placebo ("Sugar Pill")
|
|---|---|---|
|
Electroencephalogram (EEG) Mismatch Negativity Paradigm (MMN)
Baseline
|
-2.2 microVolts
Standard Deviation 2.16
|
-1.84 microVolts
Standard Deviation 1.42
|
|
Electroencephalogram (EEG) Mismatch Negativity Paradigm (MMN)
Week 4
|
-2.15 microVolts
Standard Deviation 1.47
|
-1.99 microVolts
Standard Deviation 1.84
|
|
Electroencephalogram (EEG) Mismatch Negativity Paradigm (MMN)
Week 8
|
-2.15 microVolts
Standard Deviation 1.66
|
-1.68 microVolts
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8Population: Participant dropped at the 8 week follow-up
Serum will be collected at baseline, 4 weeks, and 8 weeks. BDNF concentrations will be quantified by enzyme-linked immunosorbent assay.
Outcome measures
| Measure |
Curcumin
n=17 Participants
Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).
Curcumin: 360 mg/day (divided into twice daily oral doses)
|
Sugar Pill
n=19 Participants
Matched placebo, 2 capsules twice daily.
Placebo: Inactive, matched placebo ("Sugar Pill")
|
|---|---|---|
|
Brain Derived Neurotrophic Factor (BDNF)
Baseline
|
11416 pg/mL
Standard Deviation 10067
|
14227 pg/mL
Standard Deviation 9371
|
|
Brain Derived Neurotrophic Factor (BDNF)
Week 4
|
15395 pg/mL
Standard Deviation 11065
|
13288 pg/mL
Standard Deviation 10565
|
|
Brain Derived Neurotrophic Factor (BDNF)
Week 8
|
14828 pg/mL
Standard Deviation 12876
|
10219 pg/mL
Standard Deviation 8571
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8The Brief Psychiatric Rating Scale (BPRS) will be the primary measure for assessing positive symptoms. We will be using the UCLA expanded 24-item version of the scale. The total score ranges from 24-168, with lower scores being better (i.e., less symptomatology).
Outcome measures
| Measure |
Curcumin
n=17 Participants
Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).
Curcumin: 360 mg/day (divided into twice daily oral doses)
|
Sugar Pill
n=19 Participants
Matched placebo, 2 capsules twice daily.
Placebo: Inactive, matched placebo ("Sugar Pill")
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS)
Baseline
|
36.1 Score on a Scale
Standard Deviation 7.7
|
38.1 Score on a Scale
Standard Deviation 9.5
|
|
Brief Psychiatric Rating Scale (BPRS)
Week 4
|
35.1 Score on a Scale
Standard Deviation 5.7
|
37.9 Score on a Scale
Standard Deviation 10.9
|
|
Brief Psychiatric Rating Scale (BPRS)
Week 8
|
36.1 Score on a Scale
Standard Deviation 8.8
|
37.1 Score on a Scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8The Clinical Assessment Interview for Negative Symptoms (CAINS) will be used to assess negative symptoms. This scale is comprised of 9 items that rate motivation and pleasure symptoms and 4 items that rate expression symptoms. We are reporting the motivation subscale. The total score can range from 0-36 (summed over the 9 items), with lower scores being better (i.e., less symptomatology).
Outcome measures
| Measure |
Curcumin
n=17 Participants
Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).
Curcumin: 360 mg/day (divided into twice daily oral doses)
|
Sugar Pill
n=19 Participants
Matched placebo, 2 capsules twice daily.
Placebo: Inactive, matched placebo ("Sugar Pill")
|
|---|---|---|
|
The Clinical Assessment Interview for Negative Symptoms (CAINS)
Baseline
|
14.2 Score on a Scale
Standard Deviation 6.8
|
16.0 Score on a Scale
Standard Deviation 5.9
|
|
The Clinical Assessment Interview for Negative Symptoms (CAINS)
Week 4
|
15.8 Score on a Scale
Standard Deviation 7.5
|
16.2 Score on a Scale
Standard Deviation 7.1
|
|
The Clinical Assessment Interview for Negative Symptoms (CAINS)
Week 8
|
15.1 Score on a Scale
Standard Deviation 6.2
|
17.9 Score on a Scale
Standard Deviation 7.8
|
Adverse Events
Curcumin
Sugar Pill
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jonathan K. Wynn, Ph.D.
VA Greater Los Angeles Healthcare System/UCLA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place