Effect of Curcumin as Nutraceutical in Patients of Depression

NCT01022632 | Completed

• 1 other identifier: Pharmacol no.01 /2008 Research
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Depression

Outcome Measures

Primary Outcomes (2)

• Response rate according to HAM-D17 scale

  6 weeks

• Mean change in HAM-D17 score

  Six weeks

Secondary Outcomes (3)

• 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

Study Arms (3)

Fluoxetine

ACTIVE COMPARATOR

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

Drug: Fluoxetine

Curcumin

EXPERIMENTAL

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

Dietary Supplement: Curcumin

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

Dietary Supplement: Curcumin and Fluoxetine

Interventions

Curcumin DIETARY_SUPPLEMENT

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

Curcumin

Fluoxetine DRUG

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

Fluoxetine

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

Curcumin and Fluoxetine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Government Medical College, Bhavnagar: lead
• Health and Family Welfare Department, Government of Gujarat, India: collaborator
• Arjuna Natural Extracts Ltd.: collaborator

Study Sites (1)

Sir Takthasinhji General Hospital

Bhavnagar, Gujarat, 364001, India

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Curcumin; Fluoxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Propylamines; Amines

Study Officials

• Dr. Bharat Panchal, MD

  Professor and Head, Department of Psychiatry, Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 26, 2009
• First Posted: December 1, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 28, 2010

Record last verified: 2010-01

Locations

IN (1)