Effect of Curcumin as Nutraceutical in Patients of Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Dietary Supplement: Curcumin; Dietary Supplement: Curcumin and Fluoxetine; Drug: Fluoxetine

• Registration Number: NCT01022632
• Lead Sponsor: Government Medical College, Bhavnagar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-11-26
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-01
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-27
• Last Update Posted: 2010-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Curcumin	Curcumin	Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks
Curcumin and Fluoxetine	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
Fluoxetine	Fluoxetine	Fluoxetine : 20 mg Once a day in morning after taking food for 6 weeks

Primary Outcome Measures

Name	Time	Method
Response rate according to HAM-D17 scale	6 weeks
Mean change in HAM-D17 score	Six weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sir Takthasinhji General Hospital; 🇮🇳 Bhavnagar, Gujarat, India