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SchizophreniaPhase 1/2NCT02104752

Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia

A Phase 1/2 study testing Curcumin in people with Schizophrenia and Cognition, run by VA Greater Los Angeles Healthcare System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia, Cognition, Psychosis
What is being tested?
Curcumin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
1 siteUnited States
Study dates
Jul 2014to Oct 2017
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • VA Greater Los Angeles

    Los Angeles, California, 90073

Other trials in United States

About this study

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.

Read the 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.

Being tested
Curcumin, Placebo
Keywords
Curcumin, Turmeric, Schizophrenia, Cognition, Psychosis
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CurcuminDrug

    Also called Theracurmin, Curcumin nanoparticles

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

  • PlaceboDrug

    Inactive, matched placebo ("Sugar Pill")

Study groups in NCT02104752
Study groupRoleWhat they receive
CurcuminExperimentalCurcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).
Receives: Drug: Curcumin
Sugar PillPlacebo comparatorMatched placebo, 2 capsules twice daily.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 4, Week 8

Secondary outcomes (4)

  1. Electroencephalogram (EEG) Mismatch Negativity Paradigm (MMN)

    A passive attention auditory oddball paradigm will be used to assess MMN. For MMN, difference waves generated by subtracting the standard from deviant event related potentials (ERP) will be analyzed. The specific electrodes used to examine each component will be chosen based on maximal activity seen by inspection of the topographical maps. More negative values indicate a larger (i.e., better) MMN response.

    Measured: Baseline, Week 4, Week 8

  2. Brain Derived Neurotrophic Factor (BDNF)

    Serum will be collected at baseline, 4 weeks, and 8 weeks. BDNF concentrations will be quantified by enzyme-linked immunosorbent assay.

    Measured: Baseline, Week 4, Week 8

  3. Brief Psychiatric Rating Scale (BPRS)

    The Brief Psychiatric Rating Scale (BPRS) will be the primary measure for assessing positive symptoms. We will be using the UCLA expanded 24-item version of the scale. The total score ranges from 24-168, with lower scores being better (i.e., less symptomatology).

    Measured: Baseline, Week 4, Week 8

  4. The Clinical Assessment Interview for Negative Symptoms (CAINS)

    The Clinical Assessment Interview for Negative Symptoms (CAINS) will be used to assess negative symptoms. This scale is comprised of 9 items that rate motivation and pleasure symptoms and 4 items that rate expression symptoms.

    We are reporting the motivation subscale. The total score can range from 0-36 (summed over the 9 items), with lower scores being better (i.e., less symptomatology).

    Measured: Baseline, Week 4, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionMay 2016
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02104752
Sponsor's protocol ID
2013-121701
Status last verified
Apr 2019
First submitted
1 Apr 2014
Last updated
15 May 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 23142609

  • 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.

    PubMed 22359574

  • 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.

    PubMed 21532153

  • 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.

    PubMed 20828991

  • 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.

    PubMed 28965778

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Curcumin in people with Schizophrenia and Cognition, run by VA Greater Los Angeles Healthcare System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) (time frame: Baseline, Week 4, Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02104752, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.

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