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Trial record 5 of 153 for:    Enzyme | curcumin

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

Tracking Information
First Submitted Date  ICMJE April 1, 2014
First Posted Date  ICMJE April 4, 2014
Results First Submitted Date  ICMJE October 30, 2017
Results First Posted Date  ICMJE May 15, 2019
Last Update Posted Date May 15, 2019
Study Start Date  ICMJE July 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2014)
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.
Change History Complete list of historical versions of study NCT02104752 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2014)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia
Official Title  ICMJE Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia
Brief Summary The investigators propose to test whether curcumin nanoparticles will improve behavioral measures and biomarkers of cognition and neuroplasticity in patients with schizophrenia who are already receiving a stable dose of antipsychotic.
Detailed Description The investigators will use a formulation of curcumin with high bioavailability that possesses a pharmacokinetic profile expected to exert biological effects. Specifically, 36 subjects will be enrolled in the double-blind randomized controlled trial. They will be randomized to curcumin or placebo for 8 weeks. At baseline, and 4 and 8 weeks, subjects will receive assessments of neurocognition (e.g., processing speed, attention and vigilance, working memory, learning, reasoning and problem solving), social cognition, EEG biomarkers (e.g., visual cortical plasticity and mismatch negativity), a serum marker of neurogenesis (BDNF levels), and clinical symptoms (positive and negative symptoms). At weeks 2 and 6 subjects will return for additional safety (e.g., vitals, side effects, akathisia) and medication adherence assessments. Improvement on the primary outcome measure (MATRICS Consensus Cognitive Battery), as well as secondary outcome measures, will be compared between participants randomized to placebo versus curcumin. The results of this study will establish whether curcumin is a viable adjunctive agent for future larger clinical trials.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Cognition
  • Psychosis
Intervention  ICMJE
  • Drug: Curcumin
    360 mg/day (divided into twice daily oral doses)
    Other Names:
    • Theracurmin
    • Curcumin nanoparticles
  • Drug: Placebo
    Inactive, matched placebo ("Sugar Pill")
Study Arms  ICMJE
  • Experimental: Curcumin
    Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).
    Intervention: Drug: Curcumin
  • Placebo Comparator: Sugar Pill
    Matched placebo, 2 capsules twice daily.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2017)
39
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2014)
36
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • DSM-5 diagnosis of schizophrenia
  • age 18 - 65 years
  • understand spoken English sufficiently to comprehend testing procedures
  • corrected vision of at least 20/30
  • currently prescribed an antipsychotic medication

Exclusion Criteria:

  • clinically significant neurological disease determined by medical history (e.g., epilepsy)
  • history of serious head injury (i.e., loss of consciousness > 1 hr., no neuropsychological sequelae, no cognitive rehabilitation post head injury)
  • sedatives or benzodiazepines within 12 hrs of testing
  • any psychiatric hospitalization within 3 months prior to study participation
  • behaviors suggesting any potential danger to self or others within 6 months prior to study participation
  • antipsychotic dose change more than 50% over the 3 months prior to study participation
  • acute medical problems or untreated chronic medical conditions within 3 months prior to study participation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02104752
Other Study ID Numbers  ICMJE 2013-121701
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael C. Davis, M.D., Ph.D., VA Greater Los Angeles Healthcare System
Study Sponsor  ICMJE VA Greater Los Angeles Healthcare System
Collaborators  ICMJE
  • Stanley Medical Research Institute
  • Theravalues, Inc.
  • University of California, Los Angeles
Investigators  ICMJE
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
PRS Account VA Greater Los Angeles Healthcare System
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP