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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875822
• Other study ID #: 06T-773
• Secondary ID: 719-325-8400 [Co
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 4, 2013
• Last updated: June 9, 2013
• Start date: June 2009
• Est. completion date: May 2012

Study information

• Verified date: April 2013
• Source: Woodbury, Michel, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Puerto Rico	Dr. Michel Woodbury-Farina	San Juan

Sponsors (2)

Lead Sponsor	Collaborator
Woodbury, Michel, M.D.	Lawson Health Research Institute

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline Negative symptom at 16 weeks	Yes
Secondary	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.	Change from Baseline neurocognitive measures at 16 weeks	Yes
Secondary	Positive symptoms	PANSS (Positive subscale) to measure the positive symptoms: hallucinations, delusions, bizzare behavior and disorganized thoughts	Change from Basline Positive symptoms at 16 weeks	Yes
Secondary	General psychopathology	The BPRS is a standardized psychiatric rating scales to measure symptoms of general psychopathology, depression, anxiety, psychosis and somatic symptoms.	Change from baseline general psychopathology at 16 weeks	Yes