We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 162 for:    curcumin

Open-label Study of Curcumin C-3 Complex in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01875822
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : June 12, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Depression Dietary Supplement: Super-Curcumin Phase 1 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2009
Primary Completion Date : October 2011
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

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.
Dietary Supplement: Super-Curcumin
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 Name: Super-Curcumin@: Curcumin C-3 complex and Bioperine


Outcome Measures

Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Neurocognition measures [ Time Frame: Change from Baseline neurocognitive measures at 16 weeks ]
    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.

  2. Positive symptoms [ Time Frame: Change from Basline Positive symptoms at 16 weeks ]
    PANSS (Positive subscale) to measure the positive symptoms: hallucinations, delusions, bizzare behavior and disorganized thoughts

  3. General psychopathology [ Time Frame: Change from baseline general psychopathology at 16 weeks ]
    The BPRS is a standardized psychiatric rating scales to measure symptoms of general psychopathology, depression, anxiety, psychosis and somatic symptoms.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875822


Locations
Puerto Rico
Dr. Michel Woodbury-Farina
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
Woodbury, Michel, M.D.
Lawson Health Research Institute
Investigators
Study Director: Michel Woodbury Farina, MD ABPN University Puerto Rico San Juan PR (US)
More Information

Responsible Party: Woodbury, Michel, M.D.
ClinicalTrials.gov Identifier: NCT01875822     History of Changes
Other Study ID Numbers: 06T-773
719-325-8400 [Coast] ( Other Identifier: Coast Inc. IRB Board review assigned number )
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: April 2013

Keywords provided by Woodbury, Michel, M.D.:
Curcumin
Epigenetics
Schizophrenia
Nitric Oxide synthetase
cognition
negative symptoms

Additional relevant MeSH terms:
Curcumin
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action