Major Depressive Disorder
Conditions
Keywords
Depression
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.
Interventions
DIETARY_SUPPLEMENTCurcumin
Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks
DRUGFluoxetine
Fluoxetine ; 20 mg Once a day in morning after taking food for 6 weeks
DIETARY_SUPPLEMENTCurcumin 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
Sponsors
Health and Family Welfare Department, Government of Gujarat, India
Arjuna Natural Extracts Ltd.
Government Medical College, Bhavnagar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate according to HAM-D17 scale | 6 weeks |
| Mean change in HAM-D17 score | Six weeks |
Secondary
| Measure | 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 |
Countries
India
Outcome results
None listed