Clinical trial NCT01022632: Effect of Curcumin as Nutraceutical in Patients of Depression
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Depression
Lead sponsor: Government Medical College, Bhavnagar
Sponsor class: OTHER
Collaborators: name: Health and Family Welfare Department, Government of Gujarat, India
name: Arjuna Natural Extracts Ltd.
First posted: 2009-12-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Response rate according to HAM-D17 scale
timeFrame: 6 weeks
measure: Mean change in HAM-D17 score
timeFrame: Six weeks
Secondary outcomes:
measure: Clinical global impression assessment
timeFrame: Six Weeks
measure: Global efficacy at the end of study
timeFrame: Six weeks
measure: Change in laboratory parameters (routine hematology and urine)
timeFrame: Six weeks
Other outcomes:
Locations:
city: Bhavnagar
country: India
facility: Sir Takthasinhji General Hospital
state: Gujarat
Study officials:
affiliation: Professor and Head, Department of Psychiatry, Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India
name: Dr. Bharat Panchal, MD
role: PRINCIPAL_INVESTIGATOR
References: