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Efficacy and Safety Curcumin in Depression

This study has been completed.
Tirat Carmel Mental Health Center
Information provided by (Responsible Party):
Vladimir Lerner, Beersheva Mental Health Center Identifier:
First received: July 25, 2012
Last updated: February 6, 2013
Last verified: December 2012
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.

Condition Intervention Phase
Major Depression
Drug: curcumin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Adjunctive Curcumin for Treatment of Depression: A Randomized, Double-blind, Placebo-controlled Study

Resource links provided by NLM:

Further study details as provided by Beersheva Mental Health Center:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: Change in the scores from baseline at six weeks ]
  • Montgomery-Asberg Depression Rating Scale [ Time Frame: Change in the scores from baseline at six weeks ]

Secondary Outcome Measures:
  • Clinical Global Impression [ Time Frame: Change in the scores from baseline at six weeks ]

Enrollment: 40
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: curcumin Drug: curcumin
500 mg/day for 6 week
Placebo Comparator: placebo Drug: curcumin
500 mg/day for 6 week


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01750359

Tirat Carmel Mental Health Center
Tirat Carmel, Israel, 84170
Sponsors and Collaborators
Vladimir Lerner
Tirat Carmel Mental Health Center
Principal Investigator: Joseph Bergman, MD Tirat Carmel
Study Director: Vladimir Lerner, MD, PhD Beersheva Mental Health Center
  More Information

Responsible Party: Vladimir Lerner, A/Professor, Head of department, Beersheva Mental Health Center Identifier: NCT01750359     History of Changes
Other Study ID Numbers: LBM-2010
IsraelMHC ( Other Identifier: Tirat Carmel &Be'er Sheva MHC )
Study First Received: July 25, 2012
Last Updated: February 6, 2013

Keywords provided by Beersheva Mental Health Center:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 22, 2017