Trial | NCT01022632  Report issue

Title

Effect of Curcumin as Nutraceutical in Patients of Depression
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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fluoxetine curcumin ...

  • Study Participants

    60
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.
Study Started
Mar 31
2009
Primary Completion
Jan 31
2010
Study Completion
Jan 31
2010
Last Update
Jan 28
2010
Estimate

Dietary Supplement Curcumin

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

Drug Fluoxetine

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

Dietary Supplement 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 Active Comparator

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

Curcumin Experimental

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

Curcumin and Fluoxetine Experimental

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

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
No Results Posted