Efficacy and Safety Curcumin in Depression

Study Overview
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Brief Summary
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Antidepressants generally do not lead to an immediate relief of symptoms. Most people will not see a significant improvement for at least 4 weeks. Studies have generally shown that the full benefits of antidepressant therapy may take as long as 8 to 12 weeks. However, this timeline is variable among individuals.Curcumin is one of the main curcuminoids isolated from this perennial herb. It possesses a variety of pharmacological activities, including anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects. Curcumin has been found to possess antidepressant action in various animal models of depression. Chronic administration of curcumin has been reported to exert antidepressant-like action in olfactory bulbectomy model of depression in rats. Although the mechanism of the antidepressant effect of curcumin is not fully understood, it is hypothesized that it acts through inhibiting the monoamine oxidase enzyme and modulating the release of serotonin and dopamine.In randomized, double-blind, placebo-controlled study 40 patients will be randomized to receive either 500 mg/day of curcumin or placebo together with antidepressants for 6 weeks.

Official Title
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The Efficacy and Safety of Adjunctive Curcumin for Treatment of Depression: A Randomized, Double-blind, Placebo-controlled Study

Conditions
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Major Depression

Intervention / Treatment
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* Drug: curcumin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Males and females in age 20-60 years Major depressive episode according to DSM-IV Clinical Global Impression Severity Scale scores more than 4 Hamilton Depression Rating Scale scores more than 21 Montgomery and Asberg Depression Rating Scale scores more than 22 Ability and willingness to sign informed consent Exclusion Criteria: Evidence of organic brain damage Mental retardation Alcohol or drug abuse An unstable medical condition Any significant medical or neurological illness Patients with a known hypersensitivity to curcumin or other components of the product Pregnant women or women who intend to become pregnant Receiving any antidepressant and mood-stabilizers

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: curcumin<br> | Drug: curcumin<br>* 500 mg/day for 6 week<br>|
| Placebo Comparator: placebo<br> | Drug: curcumin<br>* 500 mg/day for 6 week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale |  | Change in the scores from baseline at six weeks | 
| Montgomery-Asberg Depression Rating Scale |  | Change in the scores from baseline at six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression |  | Change in the scores from baseline at six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antioxidants, curcumin, depression