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
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Depression||Dietary Supplement: Super-Curcumin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||May 2012|
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
- 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
- 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.
- 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
- 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.
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
|Dr. Michel Woodbury-Farina|
|San Juan, Puerto Rico, 00918|
|Study Director:||Michel Woodbury Farina, MD ABPN||University Puerto Rico San Juan PR (US)|