Effect of Curcumin as Nutraceutical in Patients of Depression

This study has been completed.
Sponsor:
Collaborators:
Health and Family Welfare Department, Government of Gujarat, India
Arjuna Natural Extracts Ltd, Kerala, India
Information provided by:
Government Medical College, Bhavnagar
ClinicalTrials.gov Identifier:
NCT01022632
First received: November 26, 2009
Last updated: January 27, 2010
Last verified: January 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Mean change in HAM-D17 score [ Time Frame: Six weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical global impression assessment [ Time Frame: Six Weeks ] [ Designated as safety issue: No ]
  • Global efficacy at the end of study [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
  • Change in laboratory parameters (routine hematology and urine) [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Kerala, India
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

No publications provided

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
Study First Received: November 26, 2009
Last Updated: January 27, 2010
Health Authority: India: Institutional Review Board

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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 29, 2014