Study Stopped
Recruitment was not achieved as expected
A Pilot Trial of Curcumin Effects on Cognition in Schizophrenia
CRC
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable schizophrenia
Started Feb 2016
Shorter than P25 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedStudy Start
First participant enrolled
February 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2017
CompletedJanuary 23, 2018
January 1, 2018
1.5 years
May 5, 2015
January 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of curcumin (MATRICS - Composite Score t score)
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 Outcomes (10)
Effect on psychiatric symptoms (PANSS - Positive Score)
8 weeks
Effect on psychiatric symptoms (PANSS- Negative Score)
8 weeks
Effect on psychiatric symptoms (PANSS- Total Score)
8 weeks
Efficacy of curcumin (MATRICS - Speed of Processing - t score)
8 weeks
Efficacy of curcumin (MATRICS - Attention/Vigilance t-score)
8 weeks
- +5 more secondary outcomes
Study Arms (2)
Curcumin 1800mg
EXPERIMENTALcurcumin capsule 600mg taken 3 times per day for 8 weeks
Placebo
PLACEBO COMPARATORplacebo capsule taken 3 times per day for 8 weeks
Interventions
Curcumin, derived from turmeric root, is an over-the-counter supplement which is tolerated well.
Eligibility Criteria
You may qualify if:
- years of age
- English speaking
- Diagnostic and Statistical Manual- IV diagnosis of schizophrenia or schizoaffective disorder based on Structured Clinical Interview for Diagnostic and Statistical Manual-IV (SCID)
- Symptomatic stability confirmed by clinical staff in the 8 weeks prior to the study
- No changes in antipsychotic medication within the last 8 weeks
- No change in antipsychotic dose in in last 4 weeks.
You may not qualify if:
- Unable to provide informed consent
- Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of alcohol/substance dependence
- Recent history of gastrointestinal bleeding or ulceration
- Recent history of gallstones and/or bile duct obstruction
- 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)
- Known intolerance to turmeric, curcumin, or curry
- Pregnancy or breast-feeding
- Current use of anti-platelet, anti-coagulant, glucocorticoid, immunosuppressants
- Daily use of non-steroidal anti-inflammatory use.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Connecticut Mental Health Center
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cenk Tek, MD
Yale Unversity School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry
Study Record Dates
First Submitted
May 5, 2015
First Posted
June 19, 2015
Study Start
February 11, 2016
Primary Completion
August 24, 2017
Study Completion
August 24, 2017
Last Updated
January 23, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will share
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.