NCT02104752

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_1 schizophrenia

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

May 15, 2019

Completed
Last Updated

May 15, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

April 1, 2014

Results QC Date

October 30, 2017

Last Update Submit

April 23, 2019

Conditions

SchizophreniaCognitionPsychosis

Keywords

CurcuminTurmericSchizophreniaCognitionPsychosis

Outcome Measures

Primary Outcomes (1)

  • Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)

    This battery was developed as part of the National Institute of Mental Health (NIMH) sponsored Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Initiative to assess cognition in clinical trials of cognition enhancing drugs. The MCCB comprises 10 tests that assess 7 cognitive domains (speed of processing, verbal memory, visual memory, working memory, reasoning and problem solving, attention/vigilance, and social cognition). The MCCB takes approximately 65 minutes to administer and provides age and gender-corrected normed T-scores, including a global composite score and cognitive domain scores. The range of T-scores is between 0 to 100 with a mean of 50. Higher scores indicate better overall cognitive functioning.

    Baseline, Week 4, Week 8

Secondary Outcomes (4)

  • Electroencephalogram (EEG) Mismatch Negativity Paradigm (MMN)

    Baseline, Week 4, Week 8

  • Brain Derived Neurotrophic Factor (BDNF)

    Baseline, Week 4, Week 8

  • Brief Psychiatric Rating Scale (BPRS)

    Baseline, Week 4, Week 8

  • The Clinical Assessment Interview for Negative Symptoms (CAINS)

    Baseline, Week 4, Week 8

Study Arms (2)

Curcumin

EXPERIMENTAL

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

Drug: Curcumin

Sugar Pill

PLACEBO COMPARATOR

Matched placebo, 2 capsules twice daily.

Drug: Placebo

Interventions

CurcuminDRUG

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

Also known as: Theracurmin, Curcumin nanoparticles
Curcumin
PlaceboDRUG

Inactive, matched placebo ("Sugar Pill")

Sugar Pill

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles

Los Angeles, California, 90073, United States

Location

Related Publications (5)

  • Hurley LL, Akinfiresoye L, Nwulia E, Kamiya A, Kulkarni AA, Tizabi Y. Antidepressant-like effects of curcumin in WKY rat model of depression is associated with an increase in hippocampal BDNF. Behav Brain Res. 2013 Feb 15;239:27-30. doi: 10.1016/j.bbr.2012.10.049. Epub 2012 Nov 8.

    PMID: 23142609BACKGROUND

  • Dong S, Zeng Q, Mitchell ES, Xiu J, Duan Y, Li C, Tiwari JK, Hu Y, Cao X, Zhao Z. Curcumin enhances neurogenesis and cognition in aged rats: implications for transcriptional interactions related to growth and synaptic plasticity. PLoS One. 2012;7(2):e31211. doi: 10.1371/journal.pone.0031211. Epub 2012 Feb 16.

    PMID: 22359574BACKGROUND

  • Sasaki H, Sunagawa Y, Takahashi K, Imaizumi A, Fukuda H, Hashimoto T, Wada H, Katanasaka Y, Kakeya H, Fujita M, Hasegawa K, Morimoto T. Innovative preparation of curcumin for improved oral bioavailability. Biol Pharm Bull. 2011;34(5):660-5. doi: 10.1248/bpb.34.660.

    PMID: 21532153BACKGROUND

  • Shamsi S, Lau A, Lencz T, Burdick KE, DeRosse P, Brenner R, Lindenmayer JP, Malhotra AK. Cognitive and symptomatic predictors of functional disability in schizophrenia. Schizophr Res. 2011 Mar;126(1-3):257-64. doi: 10.1016/j.schres.2010.08.007. Epub 2010 Sep 15.

    PMID: 20828991BACKGROUND

  • Wynn JK, Green MF, Hellemann G, Karunaratne K, Davis MC, Marder SR. The effects of curcumin on brain-derived neurotrophic factor and cognition in schizophrenia: A randomized controlled study. Schizophr Res. 2018 May;195:572-573. doi: 10.1016/j.schres.2017.09.046. Epub 2017 Sep 29. No abstract available.

    PMID: 28965778DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Results Point of Contact

Title
Jonathan K. Wynn, Ph.D.
Organization
VA Greater Los Angeles Healthcare System/UCLA
jkwynn@ucla.edu
(310) 478-3711

Study Officials

  • Stephen R Marder, M.D.

    VA Greater Los Angeles

    PRINCIPAL INVESTIGATOR

  • Jonathan K Wynn, Ph.D.

    VA Greater Los Angeles

    PRINCIPAL INVESTIGATOR

  • Michael C Davis, M.D.,Ph.D.

    VA Greater Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

April 1, 2014

First Posted

April 4, 2014

Study Start

July 1, 2014

Primary Completion

May 1, 2016

Study Completion

October 1, 2017

Last Updated

May 15, 2019

Results First Posted

May 15, 2019

Record last verified: 2019-04

Locations

US(1)