Effect of Curcumin as Nutraceutical in Patients of Depression

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Dietary Supplement: Curcumin
* Drug: Fluoxetine
* Dietary Supplement: Curcumin and Fluoxetine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluoxetine<br>Fluoxetine : 20 mg Once a day in morning after taking food for 6 weeks | Drug: Fluoxetine<br>* Fluoxetine ; 20 mg Once a day in morning after taking food for 6 weeks<br>|
| Experimental: Curcumin<br>Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks | Dietary Supplement: Curcumin<br>* Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks<br>|
| Experimental: Curcumin and Fluoxetine<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression