A Pilot Trial of Curcumin Effects on Cognition in Schizophrenia (CRC)

January 18, 2018 updated by: Cenk Tek, Yale University
This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial of curcumin for the treatment of cognitive impairment in schizophrenia.The primary aim of this pilot trial is to provide an effect size estimate for the efficacy of curcumin in improving cognitive functioning in schizophrenia. Secondary goals are to determine the effect of curcumin over time on negative and positive symptoms, in association with inflammatory markers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial of curcumin for the treatment of cognitive impairment in schizophrenia. Cognitive impairment and persistent negative symptoms are the core dimensions of schizophrenia; however current antipsychotic treatment fails to address this issue. Evidence suggests cognitive impairment is not only limited to patients with late-stage schizophrenia. High rates of cognitive impairment in patients with first episode psychosis indicate that cognitive impairment is not solely a consequence of long-term antipsychotic treatment, but rather is an enduring problem over the course of schizophrenia. Likewise, negative symptoms persist throughout its entire course, and are associated with poor overall functioning. Currently, there are no pharmacological agents that specifically aim to treat cognitive functioning and persistent negative symptoms; therefore, there is growing interest in the development of effective treatments for this unmet need.

The primary aim of this pilot trial is to provide an effect size estimate for the efficacy of curcumin in improving cognitive functioning in schizophrenia. Secondary goals are to determine the effect of curcumin over time on negative and positive symptoms, in association with inflammatory markers. Eligible participants will be randomized to curcumin (n=20) or placebo (n=20) in a 1:1 ratio. A commercially available surface-controlled water soluble form of 600mg curcumin (10% formulation) or matching placebo capsules will be administered three times a day for a total of 8 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Connecticut Mental Health Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. 18 - 65 years of age
  2. English speaking
  3. Diagnostic and Statistical Manual- IV diagnosis of schizophrenia or schizoaffective disorder based on Structured Clinical Interview for Diagnostic and Statistical Manual-IV (SCID)
  4. Symptomatic stability confirmed by clinical staff in the 8 weeks prior to the study
  5. No changes in antipsychotic medication within the last 8 weeks
  6. No change in antipsychotic dose in in last 4 weeks.

Exclusion criteria are:

  1. Unable to provide informed consent
  2. Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of alcohol/substance dependence
  3. Recent history of gastrointestinal bleeding or ulceration
  4. Recent history of gallstones and/or bile duct obstruction
  5. Significant uncontrolled systemic illness (e.g. chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, chronic infectious disease, chronic autoimmune disease)
  6. Known intolerance to turmeric, curcumin, or curry
  7. Pregnancy or breast-feeding
  8. Current use of anti-platelet, anti-coagulant, glucocorticoid, immunosuppressants
  9. Daily use of non-steroidal anti-inflammatory use.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Curcumin 1800mg
curcumin capsule 600mg taken 3 times per day for 8 weeks
Dietary supplement: curcumin 1800mg
Curcumin, derived from turmeric root, is an over-the-counter supplement which is tolerated well.
Other Names:
  • theracurmin
Placebo Comparator: Placebo
placebo capsule taken 3 times per day for 8 weeks
Dietary supplement: Placebo
oral placebo capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of curcumin (MATRICS - Composite Score t score)
Time Frame: 8 weeks
The primary outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores (MATRICS Consensus Cognitive Battery Composite Score) between baseline and endpoint based on medication assignment.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect on psychiatric symptoms (PANSS - Positive Score)
Time Frame: 8 weeks
Secondary outcome will be the effect of curcumin over time on negative and positive symptoms. This will be measured by comparing change in scores on PANSS (Positive and Negative Symptom Scale - Positive Symptom Score 7 min, 49 max) between baseline and endpoint based on medication assignment.
8 weeks
Effect on psychiatric symptoms (PANSS- Negative Score)
Time Frame: 8 weeks
Secondary aim is to determine the effect of curcumin over time on negative and positive symptoms. This will be measured by comparing change in scores on PANSS (Positive and Negative Symptom Scale - Negative Symptom Score - 7 min, 49 max) between baseline and endpoint based on medication assignment.
8 weeks
Effect on psychiatric symptoms (PANSS- Total Score)
Time Frame: 8 weeks
Secondary aim is to determine the effect of curcumin over time on negative and positive symptoms. This will be measured by comparing change in scores on PANSS (Positive and Negative Symptom Scale - Total score 14 min, 112 max) between baseline and endpoint based on medication assignment.
8 weeks
Efficacy of curcumin (MATRICS - Speed of Processing - t score)
Time Frame: 8 weeks
This outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores. MATRICS Consensus Cognitive Battery Speed of Processing is calculated from the composite of t-scores for trail making task (time in seconds - max 300), Brief Assessment of Cognition in Schizophrenia (number of correct responses, max 110), and fluency/animal naming (number of animals named in 60 seconds) between baseline and endpoint based on medication assignment.
8 weeks
Efficacy of curcumin (MATRICS - Attention/Vigilance t-score)
Time Frame: 8 weeks
This outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores. MATRICS Consensus Cognitive Battery Attention/Vigilance is calculated as the computer-generated score from the Continuous Performance Test - Identical Pairs (CPT-IP) program between baseline and endpoint based on medication assignment.
8 weeks
Efficacy of curcumin (MATRICS - Working Memory t-score)
Time Frame: 8 weeks
This outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores. MATRICS Consensus Cognitive Battery Working Memory is calculated from the composite of t-scores for the Wechsler Memory Scale-III: Spacial Span (Sum of forward and backward total scores, range 0-32) between baseline and endpoint based on medication assignment.
8 weeks
Efficacy of curcumin (MATRICS - Verbal Learning t-score)
Time Frame: 8 weeks
This outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores. MATRICS Consensus Cognitive Battery Verbal Learning is calculated as the total number of words recalled from the Hopkins-Verbal Learning Test-revised (range 0-36) between baseline and endpoint based on medication assignment.
8 weeks
Efficacy of curcumin (MATRICS - Visual Learning t-score)
Time Frame: 8 weeks
This outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores. MATRICS Consensus Cognitive Battery Visual Learning is calculated as the total score from the Brief Visuospacial Memory Test - revised (range 0-36) between baseline and endpoint based on medication assignment.
8 weeks
Efficacy of curcumin (MATRICS - Reasoning and Problem Solving t-score)
Time Frame: 8 weeks
This outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores. MATRICS Consensus Cognitive Battery Reasoning and Problem Solving is calculated as the total score for the 7 mazes as part of the Neuropsychological Assessment Battery (NAB) mazes (range 0-26) between baseline and endpoint based on medication assignment.
8 weeks
Efficacy of curcumin (MATRICS - Social Cognition t-score)
Time Frame: 8 weeks
This outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores. MATRICS Consensus Cognitive Battery Social Cognition is a computer generated branch score calculated from performance on the Mayer-Salovey-Caruso Emotional Intellegence Test (MSCEIT): Managing Emotions between baseline and endpoint based on medication assignment.
8 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cenk Tek, MD, Yale Unversity School of Medicine

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 24, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 24, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1412015121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All de-identified data resulting from this award involving human subjects will be submitted to the NIMH Data Archive (NDA) - National Database for Clinical Trials Related to Mental Illness (NDCT) The Principal Investigator will work with NDA support staff to plan an appropriate data submission schedule and provide information on the steps for submission and sharing of data. Communication of this data sharing plan to appropriate research staff to ensure the timely submission of data. All human subject data provided will include an NDA Global Unique Identifier (GUID) and will not include personally identifiable information (PII). Analyzed data will be submitted no later than the time of publication. Even if a publication focuses on only part of an analyzed dataset, the entire analyzed dataset will be submitted when the first paper is published. All data made available for public use via NDA will be de-identified data.

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 1800mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings