A Pilot Trial of Curcumin Effects on Cognition in Schizophrenia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Yale University
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Efficacy of curcumin (MATRICS - Composite Score t score)
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Curcumin 1800mg
curcumin capsule 600mg taken 3 times per day for 8 weeks
Intervention: curcumin 1800mg (Dietary Supplement)
Placebo
placebo capsule taken 3 times per day for 8 weeks
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
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 Outcomes
- Efficacy of curcumin (MATRICS - Attention/Vigilance t-score)(8 weeks)
- Efficacy of curcumin (MATRICS - Visual Learning t-score)(8 weeks)
- Efficacy of curcumin (MATRICS - Speed of Processing - t score)(8 weeks)
- Efficacy of curcumin (MATRICS - Reasoning and Problem Solving t-score)(8 weeks)
- Efficacy of curcumin (MATRICS - Working Memory t-score)(8 weeks)
- Efficacy of curcumin (MATRICS - Verbal Learning t-score)(8 weeks)
- 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 - Social Cognition t-score)(8 weeks)
Investigators
Cenk Tek
Associate Professor of Psychiatry
Yale University