Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia

VA Greater Los Angeles Healthcare System

Status and phase: Completed; Phase 2; Phase 1

Conditions: Psychosis; Schizophrenia; Cognition

Treatments: Drug: Curcumin; Drug: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT02104752

2013-121701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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39 participants in 2 patient groups, including a placebo group

Curcumin

Experimental group

Description:

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

Treatment:

Drug: Curcumin

Sugar Pill

Placebo Comparator group

Description:

Matched placebo, 2 capsules twice daily.

Treatment:

Drug: Placebo