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Effect of Curcumin as Nutraceutical in Patients of Depression

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ClinicalTrials.gov Identifier: NCT01022632
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : January 28, 2010
Sponsor:
Collaborators:
Health and Family Welfare Department, Government of Gujarat, India
Arjuna Natural Extracts Ltd.
Information provided by:
Government Medical College, Bhavnagar

Tracking Information
First Submitted Date  ICMJE November 26, 2009
First Posted Date  ICMJE December 1, 2009
Last Update Posted Date January 28, 2010
Study Start Date  ICMJE March 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2010)
  • Response rate according to HAM-D17 scale [ Time Frame: 6 weeks ]
  • Mean change in HAM-D17 score [ Time Frame: Six weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
Change in 17-point Hamilton depression scale score [ Time Frame: Six weeks ]
Change History Complete list of historical versions of study NCT01022632 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2010)
  • Clinical global impression assessment [ Time Frame: Six Weeks ]
  • Global efficacy at the end of study [ Time Frame: Six weeks ]
  • Change in laboratory parameters (routine hematology and urine) [ Time Frame: Six weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
  • Clinical global severity and clinical global change [ Time Frame: Six Weeks ]
  • Change in laboratory parameters (routine hematology and urine) [ Time Frame: Six weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Curcumin as Nutraceutical in Patients of Depression
Official Title  ICMJE A Randomized, Active Controlled, Open Label, Parallel Group Study to Compare the Efficacy of Extract of Curcuma Longa (Turmeric) With Fluoxetine and to Study Its Effect as an Add on Therapy to Fluoxetine in Patients of Depression
Brief Summary The purpose of this study is to find the effect of commonly used nutraceutical curcumin ( extract of Curcuma longa, commonly called 'Haldi' in Hindi) in patients of depression.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Dietary Supplement: Curcumin
    Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks
  • Drug: Fluoxetine
    Fluoxetine ; 20 mg Once a day in morning after taking food for 6 weeks
  • Dietary Supplement: Curcumin and Fluoxetine
    Curcumin 500 12 hourly after taking food in morning and evening and Fluoxetine 20 mg Once a day in morning after taking food for 6 weeks
Study Arms  ICMJE
  • Active Comparator: Fluoxetine
    Fluoxetine : 20 mg Once a day in morning after taking food for 6 weeks
    Intervention: Drug: Fluoxetine
  • Experimental: Curcumin
    Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks
    Intervention: Dietary Supplement: Curcumin
  • Experimental: Curcumin and Fluoxetine
    Curcumin 500 12 hourly after taking food in morning and evening and Fluoxetine 20 mg Once a day in morning after taking food for 6 weeks
    Intervention: Dietary Supplement: Curcumin and Fluoxetine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Depression as diagnosed under DSM-IV Axis I Disorders.
  • Score greater than 7 but less then 35 on the 17-item Hamilton Depression (HAM-D) Scale at screening.
  • The patient has relative(s) to care for him/her
  • Informed consent obtained from the patient or relative

Exclusion Criteria:

  • Scores greater than 2 on the "suicide" item of HAM-D, or history of suicide attempt(s) in the past 12 months.
  • Current suicidal or homicidal risk, as determined by the investigator.
  • Clinically significant liver disease (such as hepatitis, cirrhosis, etc); or clinically significant elevation of liver enzyme tests (two times the upper limit of normal.
  • History of seizure disorder (other than febrile).
  • Patient who has had monoamine oxidase inhibitor , any selective serotonin reuptake inhibitor or any other antidepressant in last 15 days
  • Any of the following DSM-IV diagnoses current (within past 3 months) schizophrenia, schizo-affective, or other psychotic disorder; bipolar disorder; current panic disorder or obsessive compulsive disorder; history of psychotic features of affective disorder (mood congruent or incongruent)
  • Patient with history of untreated or unstable thyroid disorder
  • Failed to respond to at least two adequate antidepressant trials (defined as 6 weeks or more treatment with either greater than or equal to 150 mg imipramine, or tricyclic equivalent), or greater than or equal to 60 mg of phenelzine, or MAOI equivalent, or greater than or equal to 100 mg of sertraline, or its SSRI equivalent.
  • Have had other investigational drugs within 30 days or other psychotropic medication within 21 days.
  • Known allergy or hypersensitivity to the study medications.
  • Receiving psychotherapies which are specifically designed to treat depression, eg, interpersonal psychotherapy during the study period.
  • Mental retardation or cognitive impairment, or any disorder that might interfere with their ability to give consent or follow study procedures and requirements.
  • In case of female patients, Abstinence or effective method of contraception throughout the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01022632
Other Study ID Numbers  ICMJE Pharmacol no.01 /2008 Research
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. C. B. Tripathi, Professor and Head , Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
Study Sponsor  ICMJE Government Medical College, Bhavnagar
Collaborators  ICMJE
  • Health and Family Welfare Department, Government of Gujarat, India
  • Arjuna Natural Extracts Ltd.
Investigators  ICMJE
Principal Investigator: Dr. Bharat Panchal, MD Professor and Head, Department of Psychiatry, Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India
PRS Account Government Medical College, Bhavnagar
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP