Recruitment

Recruitment Status
Completed

Inclusion Criterias

Stable antipsychotic dosage at least 1 month
SANS (Scale of Negative Symptoms of Schizophrenia ) > 30
Male or Female ,
...
Stable antipsychotic dosage at least 1 month
SANS (Scale of Negative Symptoms of Schizophrenia ) > 30
Male or Female ,
Male or female:
DSMIV (Diagnostic Statistical Manual -TR version) Schizophrenia
age 18-65 yrs

Exclusion Criterias

Regular Use of NSAID (non-steroidal anti-inflammatory drugs)
Recent myocardial infarction
Current Substance use Disorder except Nicotine dependence
...
Regular Use of NSAID (non-steroidal anti-inflammatory drugs)
Recent myocardial infarction
Current Substance use Disorder except Nicotine dependence
Poorly controlled diabetes mellitus Type I or Type II
Neurological disorders: epilepsy, stroke
Allergic reaction to Curcumin
Chronic liver & gallbladder diseases
cancer History
Hamilton Depression Scale Hamilton Depression Rating Scale( HAM-D-17 item) > 24 -
Pregnancy and breast-fed.
Recent GERD (Gastroesophageal Reflux Disorder)
untreated or severe hypertension
Unstable angina,

Summary

Conditions
  • Depression
  • Schizoaffective Disorder
  • Schizophrenia
Type
Interventional
Phase
Phase 1 & Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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 negat...

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.

Inclusion Criterias

Stable antipsychotic dosage at least 1 month
SANS (Scale of Negative Symptoms of Schizophrenia ) > 30
Male or Female ,
...
Stable antipsychotic dosage at least 1 month
SANS (Scale of Negative Symptoms of Schizophrenia ) > 30
Male or Female ,
Male or female:
DSMIV (Diagnostic Statistical Manual -TR version) Schizophrenia
age 18-65 yrs

Exclusion Criterias

Regular Use of NSAID (non-steroidal anti-inflammatory drugs)
Recent myocardial infarction
Current Substance use Disorder except Nicotine dependence
...
Regular Use of NSAID (non-steroidal anti-inflammatory drugs)
Recent myocardial infarction
Current Substance use Disorder except Nicotine dependence
Poorly controlled diabetes mellitus Type I or Type II
Neurological disorders: epilepsy, stroke
Allergic reaction to Curcumin
Chronic liver & gallbladder diseases
cancer History
Hamilton Depression Scale Hamilton Depression Rating Scale( HAM-D-17 item) > 24 -
Pregnancy and breast-fed.
Recent GERD (Gastroesophageal Reflux Disorder)
untreated or severe hypertension
Unstable angina,

Locations

San Juan, 00918
San Juan, 00918

Tracking Information

NCT #
NCT01875822
Collaborators
Lawson Health Research Institute
Investigators
Study Director: Michel Woodbury Farina, MD ABPN University Puerto Rico San Juan PR (US)