- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01875822
Open-label Study of Curcumin C-3 Complex in Schizophrenia
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 00918
- Dr. Michel Woodbury-Farina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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 -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supercurcumin
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.
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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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Negative Symptoms
Time Frame: Change from baseline Negative symptom at 16 weeks
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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 -------------------------------------------------------------------------------- |
Change from baseline Negative symptom at 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurocognition measures
Time Frame: Change from Baseline neurocognitive measures at 16 weeks
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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.
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Change from Baseline neurocognitive measures at 16 weeks
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Positive symptoms
Time Frame: Change from Basline Positive symptoms at 16 weeks
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PANSS (Positive subscale) to measure the positive symptoms: hallucinations, delusions, bizzare behavior and disorganized thoughts
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Change from Basline Positive symptoms at 16 weeks
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General psychopathology
Time Frame: Change from baseline general psychopathology at 16 weeks
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The BPRS is a standardized psychiatric rating scales to measure symptoms of general psychopathology, depression, anxiety, psychosis and somatic symptoms.
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Change from baseline general psychopathology at 16 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Michel Woodbury Farina, MD ABPN, University Puerto Rico San Juan PR (US)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Psychotic Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- 06T-773
- 719-325-8400 [Coast] (Other Identifier: Coast Inc. IRB Board review assigned number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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