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Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia

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ClinicalTrials.gov Identifier: NCT02104752
Recruitment Status : Completed
First Posted : April 4, 2014
Results First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
Stanley Medical Research Institute
Theravalues, Inc.
University of California, Los Angeles
Information provided by (Responsible Party):
Michael C. Davis, M.D., Ph.D., VA Greater Los Angeles Healthcare System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Schizophrenia
Cognition
Psychosis
Interventions Drug: Curcumin
Drug: Placebo
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Curcumin Sugar Pill
Hide Arm/Group Description

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)

Matched placebo, 2 capsules twice daily.

Placebo: Inactive, matched placebo ("Sugar Pill")
Period Title: Overall Study
Started 18 21
Completed 17 19
Not Completed 1 2
Reason Not Completed
Withdrawal by Subject             1             0
Weight gain; unrelated anxiety             0             2
Arm/Group Title Curcumin Sugar Pill Total
Hide Arm/Group Description

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)

Matched placebo, 2 capsules twice daily.

Placebo: Inactive, matched placebo ("Sugar Pill")

 Total of all reporting groups
Overall Number of Baseline Participants 17 19 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 19 participants 36 participants
50.1  (9.6) 50.9  (10.6) 50.5  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 19 participants 36 participants
Female
6
  35.3%
0
   0.0%
6
  16.7%
Male
11
  64.7%
19
 100.0%
30
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 19 participants 36 participants
17 19 36
1.Primary Outcome
Title Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Hide Description 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.
Time Frame Baseline, Week 4, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin Sugar Pill
Hide Arm/Group Description:

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)

Matched placebo, 2 capsules twice daily.

Placebo: Inactive, matched placebo ("Sugar Pill")
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Baseline 36.6  (15.1) 32.9  (10.3)
Week 4 36.3  (14.5) 33.8  (11.0)
Week 8 35.8  (14.5) 33.9  (9.7)
2.Secondary Outcome
Title Electroencephalogram (EEG) Mismatch Negativity Paradigm (MMN)
Hide Description A 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.
Time Frame Baseline, Week 4, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin Sugar Pill
Hide Arm/Group Description:

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)

Matched placebo, 2 capsules twice daily.

Placebo: Inactive, matched placebo ("Sugar Pill")
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: microVolts
Baseline -2.2  (2.16) -1.84  (1.42)
Week 4 -2.15  (1.47) -1.99  (1.84)
Week 8 -2.15  (1.66) -1.68  (1.10)
3.Secondary Outcome
Title Brain Derived Neurotrophic Factor (BDNF)
Hide Description Serum will be collected at baseline, 4 weeks, and 8 weeks. BDNF concentrations will be quantified by enzyme-linked immunosorbent assay.
Time Frame Baseline, Week 4, Week 8
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Hide Analysis Population Description
Participant dropped at the 8 week follow-up
Arm/Group Title Curcumin Sugar Pill
Hide Arm/Group Description:

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)

Matched placebo, 2 capsules twice daily.

Placebo: Inactive, matched placebo ("Sugar Pill")
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline Number Analyzed 17 participants 19 participants
11416  (10067) 14227  (9371)
Week 4 Number Analyzed 17 participants 19 participants
15395  (11065) 13288  (10565)
Week 8 Number Analyzed 17 participants 18 participants
14828  (12876) 10219  (8571)
4.Secondary Outcome
Title Brief Psychiatric Rating Scale (BPRS)
Hide Description The 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).
Time Frame Baseline, Week 4, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin Sugar Pill
Hide Arm/Group Description:

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)

Matched placebo, 2 capsules twice daily.

Placebo: Inactive, matched placebo ("Sugar Pill")
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Baseline 36.1  (7.7) 38.1  (9.5)
Week 4 35.1  (5.7) 37.9  (10.9)
Week 8 36.1  (8.8) 37.1  (10.7)
5.Secondary Outcome
Title The Clinical Assessment Interview for Negative Symptoms (CAINS)
Hide Description

The 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).
Time Frame Baseline, Week 4, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin Sugar Pill
Hide Arm/Group Description:

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)

Matched placebo, 2 capsules twice daily.

Placebo: Inactive, matched placebo ("Sugar Pill")
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Baseline 14.2  (6.8) 16.0  (5.9)
Week 4 15.8  (7.5) 16.2  (7.1)
Week 8 15.1  (6.2) 17.9  (7.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Curcumin Sugar Pill
Hide Arm/Group Description

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)

Matched placebo, 2 capsules twice daily.

Placebo: Inactive, matched placebo ("Sugar Pill")
All-Cause Mortality
Curcumin Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Curcumin Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Curcumin Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/19 (0.00%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jonathan K. Wynn, Ph.D.
Organization: VA Greater Los Angeles Healthcare System/UCLA
Phone: (310) 478-3711 ext 44957
EMail: jkwynn@ucla.edu
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Michael C. Davis, M.D., Ph.D., VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier: NCT02104752     History of Changes
Other Study ID Numbers: 2013-121701
First Submitted: April 1, 2014
First Posted: April 4, 2014
Results First Submitted: October 30, 2017
Results First Posted: May 15, 2019
Last Update Posted: May 15, 2019