Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia

April 23, 2019 updated by: Michael C. Davis, M.D., Ph.D., VA Greater Los Angeles Healthcare System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90073
        • VA Greater Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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")

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 4, Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 4, Week 8
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.
Baseline, Week 4, Week 8
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).
Baseline, Week 4, Week 8
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).
Baseline, Week 4, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Greater Los Angeles Healthcare System

Collaborators

University of California, Los Angeles
Stanley Medical Research Institute
Theravalues, Inc.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

April 1, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-121701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Curcumin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe