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Effect of Curcumin as Nutraceutical in Patients of Depression

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

Condition Intervention
Major Depressive Disorder Dietary Supplement: Curcumin Drug: Fluoxetine Dietary Supplement: Curcumin and Fluoxetine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Government Medical College, Bhavnagar:

Primary Outcome Measures:
  • Response rate according to HAM-D17 scale [ Time Frame: 6 weeks ]
  • Mean change in HAM-D17 score [ Time Frame: Six weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: March 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fluoxetine
Fluoxetine : 20 mg Once a day in morning after taking food for 6 weeks
Drug: Fluoxetine
Fluoxetine ; 20 mg Once a day in morning after taking food for 6 weeks
Experimental: Curcumin
Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks
Dietary Supplement: Curcumin
Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks
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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01022632


Locations
India
Sir Takthasinhji General Hospital
Bhavnagar, Gujarat, India, 364001
Sponsors and Collaborators
Government Medical College, Bhavnagar
Health and Family Welfare Department, Government of Gujarat, India
Arjuna Natural Extracts Ltd.
Investigators
Principal Investigator: Dr. Bharat Panchal, MD Professor and Head, Department of Psychiatry, Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India
  More Information

Responsible Party: Dr. C. B. Tripathi, Professor and Head , Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
ClinicalTrials.gov Identifier: NCT01022632     History of Changes
Other Study ID Numbers: Pharmacol no.01 /2008 Research
First Submitted: November 26, 2009
First Posted: December 1, 2009
Last Update Posted: January 28, 2010
Last Verified: January 2010

Keywords provided by Government Medical College, Bhavnagar:
Depression

Additional relevant MeSH terms:
Fluoxetine
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Curcumin
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents


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