Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Schizophrenia, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/3/2017 |
| Start Date: | July 2014 |
| End Date: | October 2017 |
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.
measures and biomarkers of cognition and neuroplasticity in patients with schizophrenia who
are already receiving a stable dose of antipsychotic.
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.
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.
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
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