Effect of Curcumin as Nutraceutical in Patients of Depression

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022632
• Other study ID #: Pharmacol no.01 /2008 Research
• Status: Completed
• Phase: N/A
• First received: November 26, 2009
• Last updated: January 27, 2010
• Start date: March 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: Government Medical College, Bhavnagar
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
India	Sir Takthasinhji General Hospital	Bhavnagar	Gujarat

Sponsors (3)

Lead Sponsor	Collaborator
Government Medical College, Bhavnagar	Arjuna Natural Extracts Ltd., Health and Family Welfare Department, Government of Gujarat, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate according to HAM-D17 scale		6 weeks	No
Primary	Mean change in HAM-D17 score		Six weeks	No
Secondary	Clinical global impression assessment		Six Weeks	No
Secondary	Global efficacy at the end of study		Six weeks	No
Secondary	Change in laboratory parameters (routine hematology and urine)		Six weeks	Yes