Effect of Curcumin as Nutraceutical in Patients of Depression

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Fluoxetine; Dietary supplement: Curcumin; Dietary supplement: Curcumin and Fluoxetine

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Bhavnagar, Gujarat, India, 364001
      • Sir Takthasinhji General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate according to HAM-D17 scale	6 weeks
Mean change in HAM-D17 score	Six weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical global impression assessment	Six Weeks
Global efficacy at the end of study	Six weeks
Change in laboratory parameters (routine hematology and urine)	Six weeks

Collaborators and Investigators

• Sponsor: Government Medical College, Bhavnagar
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: November 26, 2009
• First Submitted That Met QC Criteria: November 30, 2009
• First Posted (Estimate): December 1, 2009

Study Record Updates

• Last Update Posted (Estimate): January 28, 2010
• Last Update Submitted That Met QC Criteria: January 27, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Fluoxetine; Curcumin
• Other Study ID Numbers: Pharmacol no.01 /2008 Research