SchizophreniaPhase 1/2NCT01875822
Open-label Study of Curcumin C-3 Complex in Schizophrenia
A Phase 1/2 study testing Super-Curcumin in people with Schizophrenia and Schizoaffective Disorder, run by Woodbury, Michel, M.D. at 1 site in Puerto Rico.
Trial summary
Current evidence suggests that schizophrenia as a serious and complex psychiatric disorder, continues to challenge mental health professionals in their search for better treatment options in the community. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Depression
- What is being tested?
- Super-Curcumin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Jun 2009to May 2012
- Phase
- Phase 1/2
- 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
- Male or female:
- DSMIV (Diagnostic Statistical Manual -TR version) Schizophrenia
- Male or Female ,
- age 18-65 yrs
- SANS (Scale of Negative Symptoms of Schizophrenia ) > 30
- Stable antipsychotic dosage at least 1 month
Who cannot join
- Current Substance use Disorder except Nicotine dependence
- Regular Use of NSAID (non-steroidal anti-inflammatory drugs)
- cancer History
- Recent myocardial infarction
- Unstable angina,
- untreated or severe hypertension
Show all 13Show fewer
- Poorly controlled diabetes mellitus Type I or Type II
- Chronic liver \& gallbladder diseases
- Recent GERD (Gastroesophageal Reflux Disorder)
- Pregnancy and breast-fed.
- Allergic reaction to Curcumin
- Neurological disorders: epilepsy, stroke
- Hamilton Depression Scale Hamilton Depression Rating Scale( HAM-D-17 item) > 24 -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Study of Curcumin C-3 Complex, the Prototypal Epigenetic Modulator, as an Augmentation Strategy to Antipsychotic Therapy,for Improving Negative Symptoms and Cognition in Schizophrenia
Current evidence suggests that schizophrenia as a serious and complex psychiatric disorder, continues to challenge mental health professionals in their search for better treatment options in the community. In the present study, the investigators hypothesized that in patients diagnosed as schizophrenia, adjunct treatment with Curry extract from the plant labeled by botanists as Curcuma Longata, formulated as Super-Curcumin@ , would bring about :1)positive behavioral changes in areas of socialization, emotional well-being, verbal communication and motivation; 2)improvement in measures of memory. Throughout the study, the proprietary product, Super-Curcumin@ consisting of Curcumin C-3 complex combined with the black pepper extract Bioperine to boost the effects of Curcumin. The study was developed to examine whether Curcumin's interaction with the two major signal pathways in the brain regulating brain-behavior: the epigenetic signal (histone modification) and the anti-inflammatory signal (inducible nitric oxide synthetase)in preclinical models is translated to beneficial effects in the treatment of schizophrenia.
Read the detailed description
Detailed Description: The overall objective of the study was to evaluate whether the standardized proprietary formulation of curcumin [Super Curcumin@ :C-3 Complex@ with Bioperine@) manufactured by American Finest Inc. NJ USA ] extracted from the curry plant (Curcuma Longata) , can improve the negative symptoms and cognitive impairments in patients diagnosed as schizophrenia and to determine the response rate in negative symptoms at 16 weeks. Response rate was defined as the positive change of minimum 30% or higher from baseline to the score measured at 16 weeks. Negative symptoms refer to the cluster of symptoms of apathy, alogia, blunted affect and lack of motivation affecting severely the ways the individual functions in the community at large. In the study, the investigators proposed to test the hypothesize that Super curcumin@ is efficacious and safe when combined with standard antipsychotic drugs in the cohort of patients diagnosed as schizophrenia. Throughout the study, the proprietary product(Super curcumin@) was used. Supercurcumin@ consisted of the primary medicinally active ingredient, Curcumin C-3 Complex, in combination with Bioperine@, the metabolic enhancer extracted from black pepper, in order to increase the systemic bioavailability of curcumin C-3 complex. For the oral formulation of Super- curcumin@: 1 gm-capsule has 1 gm of curcumin C-3 complex and 5 mg of Bioperine@ . The study protocol consisted of recruiting subjects with diagnosed as schizophrenia who would be receiving either 1 gm or 4 gm of Super-Curcumin@ given orally once daily for 16 weeks, on negative symptoms and cognition. For assessing the safety and tolerability of Supercurcumin@ , the study protocol required that the patients would be monitored regularly for vital signs:blood pressure, pulse,body weight, routine blood chemistry and comprehensive adverse events profile (Treatment Emergent Adverse Events checklist) including the AIMS (Abnormal Involuntary Movement Scale). At baseline and at regular intervals throughout the 16-week treatment period, standardized measures of negative and positive symptoms and neurocognition would be administered to examine the efficacy of Curcumin C-3 complex in schizophrenia. For analysing the results, within-subject pre- and post-treatment responses would be subject to statistical procedures to evaluate whether Super-Curcumin@ can ameliorate the persistent negative symptoms and cognitive deficits in schizophrenia.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Depression
- Being tested
- Super-Curcumin
- Keywords
- Curcumin, Epigenetics, Schizophrenia, Nitric Oxide synthetase, cognition, negative symptoms
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super-CurcuminDietary supplement
Also called Super-Curcumin@: Curcumin C-3 complex and Bioperine
The investigators are comparing the effects of the two dosages of Super-Curcumin@ capsules in the sample of subjects diagnosed as DSM IV-R schizophrenia
| Study group | Role | What they receive |
|---|---|---|
| Supercurcumin | Experimental | The study protocol stipulates that subjects diagnosed as DSM IV-TR (Diagnostic Statistical Manual IV-Transitional Revised) would be receiving either 1 gm Super-Curcumin@ capsule once daily or 4 gm Super-Curcumin@ once daily for a total of 16 weeks. Super-Curcumin@ in capsule form is a patented formulation of curcumin certified by Sabinsa Corp.NJ USA and produced by America's Finest Inc. 1 gm-capsule Super-Curcumin@ consist of 1 gm Curcumin C-3 complex and 5 mg of Bioperine. Receives: Dietary Supplement: Super-Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Symptoms
PANSS (Positive and Negative Symptom scale).
The PANSS has three subscales:
1.Positive symptoms Subscale: delusions, hallucinations , and bizarre behavior; 2.Negative symptoms Subscale: alogia, anhedonia, social withdrawal, lack of motivation 3.General psychopathology Subscale: social interactions, anxiety, sleep, energy level
--------------------------------------------------------------------------------
Measured: Change from baseline Negative symptom at 16 weeks
Secondary outcomes (3)
Neurocognition measures
The CNS Vital Sign@ is a standardized computerized battery of neurocognitive tests to be administered by trained research personnel to measure neurocognitive domains of memory, attention, logical reasoning, visual-spatial function and executive function.
Measured: Change from Baseline neurocognitive measures at 16 weeks
Positive symptoms
PANSS (Positive subscale) to measure the positive symptoms: hallucinations, delusions, bizzare behavior and disorganized thoughts
Measured: Change from Basline Positive symptoms at 16 weeks
General psychopathology
The BPRS is a standardized psychiatric rating scales to measure symptoms of general psychopathology, depression, anxiety, psychosis and somatic symptoms.
Measured: Change from baseline general psychopathology at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJun 2009
- Primary completionOct 2011
- Study completionMay 2012
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woodbury, Michel, M.D.
- Collaborators
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Responsible party
- Sponsor
- Investigators
- Michel Woodbury Farina, MD ABPN, Study director, University Puerto Rico San Juan PR (US)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875822
- Sponsor's protocol ID
- 06T-773
- Other IDs
- 719-325-8400 [Coast]
- Status last verified
- Apr 2013
- First submitted
- 4 Jun 2013
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study of Curcumin C-3 Complex, the Prototypal Epigenetic Modulator, as an Augmentation Strategy to Antipsychotic Therapy,for Improving Negative Symptoms and Cognition in Schizophrenia
- ClinicalTrials.gov ID
- NCT01875822
- Acronym / sponsor ID
- 06T-773
- Conditions
- Schizophrenia, Schizoaffective Disorder, Depression
- Keywords
- Curcumin, Epigenetics, Schizophrenia, Nitric Oxide synthetase, cognition, negative symptoms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Woodbury, Michel, M.D.
- Collaborators
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Study start
- Jun 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 12 Jun 2013 (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.
Current evidence suggests that schizophrenia as a serious and complex psychiatric disorder, continues to challenge mental health professionals in their search for better treatment options in the community. In the present study, the investigators hypothesized that in patients diagnosed as schizophrenia, adjunct treatment with Curry extract from the plant labeled by botanists as Curcuma Longata, formulated as Super-Curcumin@ , would bring about :1)positive behavioral changes in areas of socialization, emotional well-being, verbal communication and motivation; 2)improvement in measures of memory. Throughout the study, the proprietary product, Super-Curcumin@ consisting of Curcumin C-3 complex combined with the black pepper extract Bioperine to boost the effects of Curcumin. The study was developed to examine whether Curcumin's interaction with the two major signal pathways in the brain regulating brain-behavior: the epigenetic signal (histone modification) and the anti-inflammatory signal (inducible nitric oxide synthetase)in preclinical models is translated to beneficial effects in the treatment of schizophrenia.
Detailed description
Detailed Description: The overall objective of the study was to evaluate whether the standardized proprietary formulation of curcumin [Super Curcumin@ :C-3 Complex@ with Bioperine@) manufactured by American Finest Inc. NJ USA ] extracted from the curry plant (Curcuma Longata) , can improve the negative symptoms and cognitive impairments in patients diagnosed as schizophrenia and to determine the response rate in negative symptoms at 16 weeks. Response rate was defined as the positive change of minimum 30% or higher from baseline to the score measured at 16 weeks. Negative symptoms refer to the cluster of symptoms of apathy, alogia, blunted affect and lack of motivation affecting severely the ways the individual functions in the community at large. In the study, the investigators proposed to test the hypothesize that Super curcumin@ is efficacious and safe when combined with standard antipsychotic drugs in the cohort of patients diagnosed as schizophrenia. Throughout the study, the proprietary product(Super curcumin@) was used. Supercurcumin@ consisted of the primary medicinally active ingredient, Curcumin C-3 Complex, in combination with Bioperine@, the metabolic enhancer extracted from black pepper, in order to increase the systemic bioavailability of curcumin C-3 complex. For the oral formulation of Super- curcumin@: 1 gm-capsule has 1 gm of curcumin C-3 complex and 5 mg of Bioperine@ . The study protocol consisted of recruiting subjects with diagnosed as schizophrenia who would be receiving either 1 gm or 4 gm of Super-Curcumin@ given orally once daily for 16 weeks, on negative symptoms and cognition. For assessing the safety and tolerability of Supercurcumin@ , the study protocol required that the patients would be monitored regularly for vital signs:blood pressure, pulse,body weight, routine blood chemistry and comprehensive adverse events profile (Treatment Emergent Adverse Events checklist) including the AIMS (Abnormal Involuntary Movement Scale). At baseline and at regular intervals throughout the 16-week treatment period, standardized measures of negative and positive symptoms and neurocognition would be administered to examine the efficacy of Curcumin C-3 complex in schizophrenia. For analysing the results, within-subject pre- and post-treatment responses would be subject to statistical procedures to evaluate whether Super-Curcumin@ can ameliorate the persistent negative symptoms and cognitive deficits in schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supercurcumin | Experimental | Dietary Supplement: Super-CurcuminThe study protocol stipulates that subjects diagnosed as DSM IV-TR (Diagnostic Statistical Manual IV-Transitional Revised) would be receiving either 1 gm Super-Curcumin@ capsule once daily or 4 gm Super-Curcumin@ once daily for a total of 16 weeks. Super-Curcumin@ in capsule form is a patented formulation of curcumin certified by Sabinsa Corp.NJ USA and produced by America's Finest Inc. 1 gm-capsule Super-Curcumin@ consist of 1 gm Curcumin C-3 complex and 5 mg of Bioperine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female:
- DSMIV (Diagnostic Statistical Manual -TR version) Schizophrenia
- Male or Female ,
- age 18-65 yrs
- SANS (Scale of Negative Symptoms of Schizophrenia ) > 30
Key exclusion criteria (13 listed)
- Current Substance use Disorder except Nicotine dependence
- Regular Use of NSAID (non-steroidal anti-inflammatory drugs)
- cancer History
- Recent myocardial infarction
- Unstable angina,
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 |
|---|---|---|
| Super-CurcuminAlso: Super-Curcumin@: Curcumin C-3 complex and BioperineThe investigators are comparing the effects of the two dosages of Super-Curcumin@ capsules in the sample of subjects diagnosed as DSM IV-R schizophrenia | Dietary supplement | Supercurcumin |
Primary outcome
Negative Symptoms
Time frame: Change from baseline Negative symptom at 16 weeks
PANSS (Positive and Negative Symptom scale). The PANSS has three subscales: 1.Positive symptoms Subscale: delusions, hallucinations , and bizarre behavior; 2.Negative symptoms Subscale: alogia, anhedonia, social withdrawal, lack of motivation 3.General psychopathology Subscale: social interactions, anxiety, sleep, energy level --------------------------------------------------------------------------------
3 secondary outcomes
Neurocognition measures
Time frame: Change from Baseline neurocognitive measures at 16 weeks
Positive symptoms
Time frame: Change from Basline Positive symptoms at 16 weeks
General psychopathology
Time frame: Change from baseline general psychopathology at 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
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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.
Michel Woodbury Farina, MD ABPN study director
University Puerto Rico San Juan PR (US)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Super-Curcumin in people with Schizophrenia and Schizoaffective Disorder, run by Woodbury, Michel, M.D. at 1 site in Puerto Rico.
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 13 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 12 Jun 2013. 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 Puerto Rico. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Negative Symptoms (time frame: Change from baseline Negative symptom at 16 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 12 Jun 2013.