NCT02104752

Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: VA Greater Los Angeles Healthcare System · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Schizophrenia
• Cognition
• Psychosis

Interventions

Type	Name	Description
DRUG	Curcumin	360 mg/day (divided into twice daily oral doses)
DRUG	Placebo	Inactive, matched placebo ("Sugar Pill")

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-05-01
• Completion: 2017-10-01
• First posted: 2014-04-04
• Last updated: 2019-05-15
• Results posted: 2019-05-15

Locations

1 site across 1 country: United States