Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia Cognition Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Curcumin

Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).

Group Type EXPERIMENTAL

Curcumin

Intervention Type DRUG

360 mg/day (divided into twice daily oral doses)

Sugar Pill

Matched placebo, 2 capsules twice daily.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inactive, matched placebo ("Sugar Pill")

Interventions

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Curcumin

360 mg/day (divided into twice daily oral doses)

Intervention Type DRUG

Placebo

Inactive, matched placebo ("Sugar Pill")

Intervention Type DRUG

Other Intervention Names

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Theracurmin Curcumin nanoparticles

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No