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
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Cognition Psychosis||Drug: Curcumin Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||October 2017|
Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).
360 mg/day (divided into twice daily oral doses)
Placebo Comparator: Sugar Pill
Matched placebo, 2 capsules twice daily.
Inactive, matched placebo ("Sugar Pill")
- Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) [ Time Frame: Baseline, Week 4, Week 8 ]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.
- Electroencephalogram (EEG) Mismatch Negativity Paradigm (MMN) [ Time Frame: Baseline, Week 4, Week 8 ]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.
- Brain Derived Neurotrophic Factor (BDNF) [ Time Frame: Baseline, Week 4, Week 8 ]Serum will be collected at baseline, 4 weeks, and 8 weeks. BDNF concentrations will be quantified by enzyme-linked immunosorbent assay.
- Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Baseline, Week 4, Week 8 ]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).
- The Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: Baseline, Week 4, Week 8 ]
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104752
|United States, California|
|VA Greater Los Angeles|
|Los Angeles, California, United States, 90073|
|Principal Investigator:||Stephen R Marder, M.D.||VA Greater Los Angeles|
|Principal Investigator:||Jonathan K Wynn, Ph.D.||VA Greater Los Angeles|
|Principal Investigator:||Michael C Davis, M.D.,Ph.D.||VA Greater Los Angeles|