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Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02104752
First Posted: April 4, 2014
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
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 Intervention Phase
Schizophrenia Cognition Psychosis Drug: Curcumin Drug: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Michael C. Davis, M.D., Ph.D., VA Greater Los Angeles Healthcare System:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 39
Study Start Date: July 2014
Study Completion Date: October 2017
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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")

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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
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
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
  More Information

Publications:
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 Submitted: April 1, 2014
First Posted: April 4, 2014
Last Update Posted: November 1, 2017
Last Verified: October 2017

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:
Curcumin
Schizophrenia
Psychotic Disorders
Mental Disorders
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Cognition Disorders
Neurocognitive Disorders
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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action