Open-label Study of Curcumin C-3 Complex in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Depression
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

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.
    

Intervention name(s): Super-Curcumin
Intervention type(s): Dietary Supplement
Intervention description(s): 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 intervention name(s): Super-Curcumin@: Curcumin C-3 complex and Bioperine
Intervention MeSH terms: Curcumin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Curcumin; Epigenetics; Schizophrenia; Nitric Oxide synthetase; cognition; negative symptoms