Clinical trial NCT01875822: Open-label Study of Curcumin C-3 Complex in Schizophrenia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Depression
Keywords: Curcumin
Epigenetics
Schizophrenia
Nitric Oxide synthetase
cognition
negative symptoms
Lead sponsor: Woodbury, Michel, M.D.
Sponsor class: INDIV
Collaborators: name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
First posted: 2013-06-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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 -

Primary outcomes:
measure: Negative Symptoms
timeFrame: Change from baseline Negative symptom at 16 weeks
Secondary outcomes:
measure: Neurocognition measures
timeFrame: Change from Baseline neurocognitive measures at 16 weeks
measure: Positive symptoms
timeFrame: Change from Basline Positive symptoms at 16 weeks
measure: General psychopathology
timeFrame: Change from baseline general psychopathology at 16 weeks
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: Dr. Michel Woodbury-Farina
Study officials:
affiliation: University Puerto Rico San Juan PR (US)
name: Michel Woodbury Farina, MD ABPN
role: STUDY_DIRECTOR
References: