We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 162 for:    curcumin

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02476708
Recruitment Status : Recruiting
First Posted : June 19, 2015
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Schizophrenia Schizoaffective Disorder Dietary Supplement: curcumin 1800mg Dietary Supplement: Placebo

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Curcumin Effects on Cognition in Schizophrenia
Study Start Date : February 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 Name: theracurmin
Placebo Comparator: Placebo
placebo capsule taken 3 times per day for 8 weeks
Dietary Supplement: Placebo
oral placebo capsule


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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. 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.

  9. 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.

  10. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
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): NCT02476708


Contacts
Contact: Cenk Tek 203-974-7484 cenk.tek@yale.edu

Locations
United States, Connecticut
Connecticut Mental Health Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Erin Sullivan    203-974-7317    erin.sullivan@yale.edu   
Contact: Cenk Tek, MD    203-974-7484    cenk.tek@yale.edu   
Principal Investigator: Cenk Tek, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Cenk Tek, MD Yale Unversity School of Medicine
More Information

Responsible Party: Cenk Tek, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT02476708     History of Changes
Other Study ID Numbers: 1412015121
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by Cenk Tek, Yale University:
schizophrenia
schizoaffective disorder
cognition
curcumin

Additional relevant MeSH terms:
Curcumin
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental 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