Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia
|ClinicalTrials.gov Identifier: NCT02104752|
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : October 23, 2017
|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")
- MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: 8 weeks ]This battery was developed as part of the NIMH sponsored 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.
- Empathic Accuracy Assessment [ Time Frame: 8 weeks ]In this task, participants will watch 12 (6 positive and 6 negative) video clips, each lasting for 2.0-2.5 min. Each clip shows an individual (referred to as a "target") while he/she discusses a positive or negative autobiographical event. For each clip, participants will use a 9-point scale to rate how positive or negative they believe the target is feeling. The primary dependent measure will be the correlations between participant ratings of the targets' emotions and the targets' ratings of their own emotions, calculated in 2-sec time epochs throughout the clip. The mean correlation across clips provides an "empathic accuracy" score for each participant. This measure takes approximately 25 minutes to administer.
- EEG Mismatch Negativity Paradigm (MMN) [ Time Frame: 8 weeks ]A passive attention auditory oddball paradigm will be used to assess MMN. For MMN, difference waves generated by subtracting the standard from deviant 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.
- EEG Visual Cortical Plasticity Paradigm [ Time Frame: 8 weeks ]This EEG measure involves assessing visual evoked potentials (VEPs) before and after exposure to tetanizing visual high-frequency stimulation (HFS). Briefly, two 2-minute baseline blocks will be presented to measure basic visual event-related potentials (ERPs), including the P100 and N100 responses. A two minute HFS period will be presented where the stimulus will flash at a rate of ~8 Hz. Three post-HFS blocks will be assessed at 2 minutes, 4 minutes, and 20 minutes after HFS presentation. The MMN procedure described above will be administered between the second and third post-HFS block. Post-HFS visual ERPs will be compared to pre-HFS ERPs to determine if HFS increased neural responses.
- Brain Derived Neurotrophic Factor [ Time Frame: 8 weeks ]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: 8 weeks ]The BPRS will be the primary measure for assessing positive symptoms. We will be using the UCLA expanded 24-item version of the scale.
- The Clinical Assessment Interview for Negative Symptoms [ Time Frame: 8 weeks ]The CAINS will be used to assess negative symptoms. This scale is comprised of 7 items that rate experience symptoms and 4 items that rate expression symptoms.
- Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 8 weeks ]The Baseline/Screening version of the scale will be administered at Visit 1, and includes items related to recent/lifetime suicidal ideation, behavior, actual attempts. The Since Last Visit version of the scale will be administered at Visits 2-5 and includes the same items in the interval time period since the last study visit.
- Udvalg for Kliniske Undersøgelser (UKU) Side Effects Rating Scale [ Time Frame: 8 weeks ]The UKU is a comprehensive side effect rating scale for psychopharmacologic medications, with 48 side effects organized into categories.
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|