Efficacy and Safety Curcumin in Depression

Phase 4

Completed

• Conditions: Major Depression
• Interventions: Drug: curcumin

• Registration Number: NCT01750359
• Lead Sponsor: Vladimir Lerner

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Study First Submitted: 2012-07-25
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-17
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
curcumin	curcumin	-
placebo	curcumin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical Global Impression	Change in the scores from baseline at six weeks

Trial Locations

Locations (1)

Tirat Carmel Mental Health Center; 🇮🇱 Tirat Carmel, Israel