Phase 2
N=39
Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia
Schizophrenia · Cognition · Psychosis
Bottom Line
View on ClinicalTrials.gov: NCT02104752 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) — 36.6; 32.9; 36.3; 33.8 Score on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Curcumin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Greater Los Angeles Healthcare System
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) |
36.6; 32.9; 36.3; 33.8; 35.8; 33.9 | — |
| SECONDARY Electroencephalogram (EEG) Mismatch Negativity Paradigm (MMN) |
-2.2; -1.84; -2.15; -1.99; -2.15; -1.68 | — |
| SECONDARY Brain Derived Neurotrophic Factor (BDNF) |
11416; 14227; 15395; 13288; 14828; 10219 | — |
| SECONDARY Brief Psychiatric Rating Scale (BPRS) |
36.1; 38.1; 35.1; 37.9; 36.1; 37.1 | — |
| SECONDARY The Clinical Assessment Interview for Negative Symptoms (CAINS) |
14.2; 16.0; 15.8; 16.2; 15.1; 17.9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02104752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.