SchizophreniaCRCNCT02476708
A Pilot Trial of Curcumin Effects on Cognition in Schizophrenia
A study testing curcumin 1800mg in people with Schizophrenia and Schizoaffective Disorder, run by Yale University at 1 site in United States.
Trial summary
This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial of curcumin for the treatment of cognitive impairment in schizophrenia.The primary aim of this pilot trial is to provide an effect size estimate for the efficacy of curcumin in improving cognitive functioning in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- curcumin 1800mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2016to 24 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 - 65 years of age
- English speaking
- Diagnostic and Statistical Manual- IV diagnosis of schizophrenia or schizoaffective disorder based on Structured Clinical Interview for Diagnostic and Statistical Manual-IV (SCID)
- Symptomatic stability confirmed by clinical staff in the 8 weeks prior to the study
- No changes in antipsychotic medication within the last 8 weeks
- No change in antipsychotic dose in in last 4 weeks.
Who cannot join
- Unable to provide informed consent
- Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of alcohol/substance dependence
- Recent history of gastrointestinal bleeding or ulceration
- Recent history of gallstones and/or bile duct obstruction
- Significant uncontrolled systemic illness (e.g. chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, chronic infectious disease, chronic autoimmune disease)
- Known intolerance to turmeric, curcumin, or curry
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- Pregnancy or breast-feeding
- Current use of anti-platelet, anti-coagulant, glucocorticoid, immunosuppressants
- Daily use of non-steroidal anti-inflammatory use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial of curcumin for the treatment of cognitive impairment in schizophrenia.The primary aim of this pilot trial is to provide an effect size estimate for the efficacy of curcumin in improving cognitive functioning in schizophrenia. Secondary goals are to determine the effect of curcumin over time on negative and positive symptoms, in association with inflammatory markers.
Read the detailed description
This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial of curcumin for the treatment of cognitive impairment in schizophrenia. Cognitive impairment and persistent negative symptoms are the core dimensions of schizophrenia; however current antipsychotic treatment fails to address this issue. Evidence suggests cognitive impairment is not only limited to patients with late-stage schizophrenia. High rates of cognitive impairment in patients with first episode psychosis indicate that cognitive impairment is not solely a consequence of long-term antipsychotic treatment, but rather is an enduring problem over the course of schizophrenia. Likewise, negative symptoms persist throughout its entire course, and are associated with poor overall functioning. Currently, there are no pharmacological agents that specifically aim to treat cognitive functioning and persistent negative symptoms; therefore, there is growing interest in the development of effective treatments for this unmet need.
The primary aim of this pilot trial is to provide an effect size estimate for the efficacy of curcumin in improving cognitive functioning in schizophrenia. Secondary goals are to determine the effect of curcumin over time on negative and positive symptoms, in association with inflammatory markers. Eligible participants will be randomized to curcumin (n=20) or placebo (n=20) in a 1:1 ratio. A commercially available surface-controlled water soluble form of 600mg curcumin (10% formulation) or matching placebo capsules will be administered three times a day for a total of 8 weeks.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- curcumin 1800mg, Placebo
- Keywords
- schizophrenia, schizoaffective disorder, cognition, curcumin
- 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.
curcumin 1800mgDietary supplement
Also called theracurmin
Curcumin, derived from turmeric root, is an over-the-counter supplement which is tolerated well.
PlaceboDietary supplement
oral placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Curcumin 1800mg | Experimental | curcumin capsule 600mg taken 3 times per day for 8 weeks Receives: Dietary Supplement: curcumin 1800mg |
| Placebo | Placebo comparator | placebo capsule taken 3 times per day for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of curcumin (MATRICS - Composite Score t score)
The primary outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores (MATRICS Consensus Cognitive Battery Composite Score) between baseline and endpoint based on medication assignment.
Measured: 8 weeks
Secondary outcomes (10)
Effect on psychiatric symptoms (PANSS - Positive Score)
Secondary outcome will be the effect of curcumin over time on negative and positive symptoms. This will be measured by comparing change in scores on PANSS (Positive and Negative Symptom Scale - Positive Symptom Score 7 min, 49 max) between baseline and endpoint based on medication assignment.
Measured: 8 weeks
Effect on psychiatric symptoms (PANSS- Negative Score)
Secondary aim is to determine the effect of curcumin over time on negative and positive symptoms. This will be measured by comparing change in scores on PANSS (Positive and Negative Symptom Scale - Negative Symptom Score - 7 min, 49 max) between baseline and endpoint based on medication assignment.
Measured: 8 weeks
Effect on psychiatric symptoms (PANSS- Total Score)
Secondary aim is to determine the effect of curcumin over time on negative and positive symptoms. This will be measured by comparing change in scores on PANSS (Positive and Negative Symptom Scale - Total score 14 min, 112 max) between baseline and endpoint based on medication assignment.
Measured: 8 weeks
Efficacy of curcumin (MATRICS - Speed of Processing - t score)
This outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores. MATRICS Consensus Cognitive Battery Speed of Processing is calculated from the composite of t-scores for trail making task (time in seconds - max 300), Brief Assessment of Cognition in Schizophrenia (number of correct responses, max 110), and fluency/animal naming (number of animals named in 60 seconds) between baseline and endpoint based on medication assignment.
Measured: 8 weeks
Efficacy of curcumin (MATRICS - Attention/Vigilance t-score)
This outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores. MATRICS Consensus Cognitive Battery Attention/Vigilance is calculated as the computer-generated score from the Continuous Performance Test - Identical Pairs (CPT-IP) program between baseline and endpoint based on medication assignment.
Measured: 8 weeks
Efficacy of curcumin (MATRICS - Working Memory t-score)
This outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores. MATRICS Consensus Cognitive Battery Working Memory is calculated from the composite of t-scores for the Wechsler Memory Scale-III: Spacial Span (Sum of forward and backward total scores, range 0-32) between baseline and endpoint based on medication assignment.
Measured: 8 weeks
Efficacy of curcumin (MATRICS - Verbal Learning t-score)
This outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores. MATRICS Consensus Cognitive Battery Verbal Learning is calculated as the total number of words recalled from the Hopkins-Verbal Learning Test-revised (range 0-36) between baseline and endpoint based on medication assignment.
Measured: 8 weeks
Efficacy of curcumin (MATRICS - Visual Learning t-score)
This outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores. MATRICS Consensus Cognitive Battery Visual Learning is calculated as the total score from the Brief Visuospacial Memory Test - revised (range 0-36) between baseline and endpoint based on medication assignment.
Measured: 8 weeks
Efficacy of curcumin (MATRICS - Reasoning and Problem Solving t-score)
This outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores. MATRICS Consensus Cognitive Battery Reasoning and Problem Solving is calculated as the total score for the 7 mazes as part of the Neuropsychological Assessment Battery (NAB) mazes (range 0-26) between baseline and endpoint based on medication assignment.
Measured: 8 weeks
Efficacy of curcumin (MATRICS - Social Cognition t-score)
This outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores. MATRICS Consensus Cognitive Battery Social Cognition is a computer generated branch score calculated from performance on the Mayer-Salovey-Caruso Emotional Intellegence Test (MSCEIT): Managing Emotions between baseline and endpoint based on medication assignment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study start11 Feb 2016
- Primary completion24 Aug 2017
- Study completion24 Aug 2017
Why it stopped: Recruitment was not achieved as expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cenk Tek, Yale University
- Investigators
- Cenk Tek, MD, Principal investigator, Yale Unversity School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476708
- Sponsor's protocol ID
- 1412015121
- Acronym
- CRC
- Status last verified
- Jan 2018
- First submitted
- 5 May 2015
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: All de-identified data resulting from this award involving human subjects will be submitted to the NIMH Data Archive (NDA) - National Database for Clinical Trials Related to Mental Illness (NDCT) The Principal Investigator will work with NDA support staff to plan an appropriate data submission schedule and provide information on the steps for submission and sharing of data. Communication of this data sharing plan to appropriate research staff to ensure the timely submission of data. All human subject data provided will include an NDA Global Unique Identifier (GUID) and will not include personally identifiable information (PII). Analyzed data will be submitted no later than the time of publication. Even if a publication focuses on only part of an analyzed dataset, the entire analyzed dataset will be submitted when the first paper is published. All data made available for public use via NDA will be de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Curcumin Effects on Cognition in Schizophrenia
- ClinicalTrials.gov ID
- NCT02476708
- Acronym / sponsor ID
- CRC / 1412015121
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, schizoaffective disorder, cognition, curcumin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was not achieved as expected
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 11 Feb 2016 (actual)
- Primary completion
- 24 Aug 2017 (actual)
- Study completion
- 24 Aug 2017 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial of curcumin for the treatment of cognitive impairment in schizophrenia.The primary aim of this pilot trial is to provide an effect size estimate for the efficacy of curcumin in improving cognitive functioning in schizophrenia. Secondary goals are to determine the effect of curcumin over time on negative and positive symptoms, in association with inflammatory markers.
Detailed description
This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial of curcumin for the treatment of cognitive impairment in schizophrenia. Cognitive impairment and persistent negative symptoms are the core dimensions of schizophrenia; however current antipsychotic treatment fails to address this issue. Evidence suggests cognitive impairment is not only limited to patients with late-stage schizophrenia. High rates of cognitive impairment in patients with first episode psychosis indicate that cognitive impairment is not solely a consequence of long-term antipsychotic treatment, but rather is an enduring problem over the course of schizophrenia. Likewise, negative symptoms persist throughout its entire course, and are associated with poor overall functioning. Currently, there are no pharmacological agents that specifically aim to treat cognitive functioning and persistent negative symptoms; therefore, there is growing interest in the development of effective treatments for this unmet need.
The primary aim of this pilot trial is to provide an effect size estimate for the efficacy of curcumin in improving cognitive functioning in schizophrenia. Secondary goals are to determine the effect of curcumin over time on negative and positive symptoms, in association with inflammatory markers. Eligible participants will be randomized to curcumin (n=20) or placebo (n=20) in a 1:1 ratio. A commercially available surface-controlled water soluble form of 600mg curcumin (10% formulation) or matching placebo capsules will be administered three times a day for a total of 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumin 1800mg | Experimental | Dietary Supplement: curcumin 1800mgcurcumin capsule 600mg taken 3 times per day for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placeboplacebo capsule taken 3 times per day for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 - 65 years of age
- English speaking
- Diagnostic and Statistical Manual- IV diagnosis of schizophrenia or schizoaffective disorder based on Structured Clinical Interview for Diagnostic and Statistical Manual-IV (SCID)
- Symptomatic stability confirmed by clinical staff in the 8 weeks prior to the study
- No changes in antipsychotic medication within the last 8 weeks
Key exclusion criteria (9 listed)
- Unable to provide informed consent
- Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of alcohol/substance dependence
- Recent history of gastrointestinal bleeding or ulceration
- Recent history of gallstones and/or bile duct obstruction
- Significant uncontrolled systemic illness (e.g. chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, chronic infectious disease, chronic autoimmune disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curcumin 1800mgAlso: theracurminCurcumin, derived from turmeric root, is an over-the-counter supplement which is tolerated well. | Dietary supplement | Curcumin 1800mg |
| Placebooral placebo capsule | Dietary supplement | Placebo |
Primary outcome
Efficacy of curcumin (MATRICS - Composite Score t score)
Time frame: 8 weeks
The primary outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores (MATRICS Consensus Cognitive Battery Composite Score) between baseline and endpoint based on medication assignment.
10 secondary outcomes
Effect on psychiatric symptoms (PANSS - Positive Score)
Time frame: 8 weeks
Effect on psychiatric symptoms (PANSS- Negative Score)
Time frame: 8 weeks
Effect on psychiatric symptoms (PANSS- Total Score)
Time frame: 8 weeks
Efficacy of curcumin (MATRICS - Speed of Processing - t score)
Time frame: 8 weeks
Efficacy of curcumin (MATRICS - Attention/Vigilance t-score)
Time frame: 8 weeks
Efficacy of curcumin (MATRICS - Working Memory t-score)
Time frame: 8 weeks
Efficacy of curcumin (MATRICS - Verbal Learning t-score)
Time frame: 8 weeks
Efficacy of curcumin (MATRICS - Visual Learning t-score)
Time frame: 8 weeks
Efficacy of curcumin (MATRICS - Reasoning and Problem Solving t-score)
Time frame: 8 weeks
Efficacy of curcumin (MATRICS - Social Cognition t-score)
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Recruitment was not achieved as expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: Yes. All de-identified data resulting from this award involving human subjects will be submitted to the NIMH Data Archive (NDA) - National Database for Clinical Trials Related to Mental Illness (NDCT) The Principal Investigator will work with NDA support staff to plan an appropriate data submission schedule and provide information on the steps for submission and sharing of data. Communication of this data sharing plan to appropriate research staff to ensure the timely submission of data. All human subject data provided will include an NDA Global Unique Identifier (GUID) and will not include personally identifiable information (PII). Analyzed data will be submitted no later than the time of publication. Even if a publication focuses on only part of an analyzed dataset, the entire analyzed dataset will be submitted when the first paper is published. All data made available for public use via NDA will be de-identified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cenk Tek, MD principal investigator
Yale Unversity School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing curcumin 1800mg in people with Schizophrenia and Schizoaffective Disorder, run by Yale University 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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 23 Jan 2018. 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.
Are results available for this study?
The study was stopped early (reason given: Recruitment was not achieved as expected). Results are not available in the source record.
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?
Efficacy of curcumin (MATRICS - Composite Score t score) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2018.