Efficacy and Safety Curcumin in Depression

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: Drug: curcumin

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Tirat Carmel, Israel, 84170
    • Tirat Carmel Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: curcumin; 500 mg/day for 6 week
Active Comparator: curcumin	Drug: curcumin; 500 mg/day for 6 week

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vladimir Lerner
• Collaborators: Tirat Carmel Mental Health Center
• Investigators: Principal Investigator: Joseph Bergman, MD, Tirat Carmel; Study Director: Vladimir Lerner, MD, PhD, Beersheva Mental Health Center

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 25, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Estimate): February 7, 2013
• Last Update Submitted That Met QC Criteria: February 6, 2013
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: depression; antioxidants; curcumin
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: LBM-2010; IsraelMHC (Other Identifier: Tirat Carmel &Be'er Sheva MHC)