Effect of Curcumin as Nutraceutical in Patients of Depression

Government Medical College, Bhavnagar

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Drug: Fluoxetine; Dietary Supplement: Curcumin; Dietary Supplement: Curcumin and Fluoxetine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01022632

Pharmacol no.01 /2008 Research

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Fluoxetine

Active Comparator group

Description:

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

Treatment:

Drug: Fluoxetine

Curcumin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Curcumin

Curcumin and Fluoxetine

Experimental group

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

Treatment:

Dietary Supplement: Curcumin and Fluoxetine