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Effect of Curcumin as Nutraceutical in Patients of Depression

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Curcumin

Fluoxetine

Curcumin and Fluoxetine

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sir Takthasinhji General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Fluoxetine

Curcumin

Curcumin and Fluoxetine

Arm Description

Fluoxetine : 20 mg Once a day in morning after taking food for 6 weeks

Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks

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

Outcomes

Primary Outcome Measures

Response rate according to HAM-D17 scale

Mean change in HAM-D17 score

Secondary Outcome Measures

Clinical global impression assessment

Global efficacy at the end of study

Change in laboratory parameters (routine hematology and urine)

Full Information

NCT ID

NCT01022632

First Posted

November 26, 2009

Last Updated

January 27, 2010

Sponsor

Government Medical College, Bhavnagar

Collaborators

Health and Family Welfare Department, Government of Gujarat, India, Arjuna Natural Extracts Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01022632

Brief Title

Effect of Curcumin as Nutraceutical in Patients of Depression

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Government Medical College, Bhavnagar

Collaborators

Health and Family Welfare Department, Government of Gujarat, India, Arjuna Natural Extracts Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fluoxetine

Arm Type

Active Comparator

Arm Description

Fluoxetine : 20 mg Once a day in morning after taking food for 6 weeks

Arm Title

Curcumin

Arm Type

Experimental

Arm Description

Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks

Arm Title

Curcumin and Fluoxetine

Arm Type

Experimental

Arm Description

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 Type

Dietary Supplement

Intervention Name(s)

Curcumin

Intervention Description

Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks

Intervention Type

Drug

Intervention Name(s)

Fluoxetine

Intervention Description

Fluoxetine ; 20 mg Once a day in morning after taking food for 6 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Curcumin and Fluoxetine

Intervention Description

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

Primary Outcome Measure Information:

Title

Response rate according to HAM-D17 scale

Time Frame

6 weeks

Title

Mean change in HAM-D17 score

Time Frame

Six weeks

Secondary Outcome Measure Information:

Title

Clinical global impression assessment

Time Frame

Six Weeks

Title

Global efficacy at the end of study

Time Frame

Six weeks

Title

Change in laboratory parameters (routine hematology and urine)

Time Frame

Six weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Bharat Panchal, MD

Organizational Affiliation

Professor and Head, Department of Psychiatry, Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sir Takthasinhji General Hospital

City

Bhavnagar

State/Province

Gujarat

ZIP/Postal Code

364001

Country

India

12. IPD Sharing Statement

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Effect of Curcumin as Nutraceutical in Patients of Depression

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