Skip to main content
OpenTrials
Completed

NCT Number: NCT01022632

Effect of Curcumin as Nutraceutical in Patients of Depression

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sir Takthasinhji General Hospital

Bhavnagar, Gujarat, 364001, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Curcumin

Dietary Supplement

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

Fluoxetine

Drug

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

Curcumin and Fluoxetine

Dietary Supplement

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

Primary outcomes

  1. Response rate according to HAM-D17 scale

    Time frame: 6 weeks

  2. Mean change in HAM-D17 score

    Time frame: Six weeks

Secondary outcomes

  1. Clinical global impression assessment

    Time frame: Six Weeks

  2. Global efficacy at the end of study

    Time frame: Six weeks

  3. Change in laboratory parameters (routine hematology and urine)

    Time frame: Six weeks

Sponsors and collaborators

Lead sponsor

Government Medical College, Bhavnagar

Other

Collaborators

  • Arjuna Natural Extracts Ltd.
  • Health and Family Welfare Department, Government of Gujarat, India

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 1, 2009
Registry last updated
Jan 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.