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Trial record 5 of 158 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

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Cognition Psychosis Drug: Curcumin Drug: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Curcumin
Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).
Drug: Curcumin
360 mg/day (divided into twice daily oral doses)
Other Names:
  • Theracurmin
  • Curcumin nanoparticles

Placebo Comparator: Sugar Pill
Matched placebo, 2 capsules twice daily.
Drug: Placebo
Inactive, matched placebo ("Sugar Pill")




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, California
VA Greater Los Angeles
Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Greater Los Angeles Healthcare System
Stanley Medical Research Institute
Theravalues, Inc.
University of California, Los Angeles
Investigators
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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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael C. Davis, M.D., Ph.D., Physician, VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier: NCT02104752     History of Changes
Other Study ID Numbers: 2013-121701
First Posted: April 4, 2014    Key Record Dates
Results First Posted: May 15, 2019
Last Update Posted: May 15, 2019
Last Verified: April 2019
Keywords provided by Michael C. Davis, M.D., Ph.D., VA Greater Los Angeles Healthcare System:
Curcumin
Turmeric
Schizophrenia
Cognition
Psychosis
Additional relevant MeSH terms:
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Enzyme Inhibitors
Schizophrenia
Psychotic Disorders
Mental Disorders
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Cognition Disorders
Neurocognitive Disorders
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action