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Efficacy and Safety Curcumin in Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01750359
First Posted: December 17, 2012
Last Update Posted: February 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tirat Carmel Mental Health Center
Information provided by (Responsible Party):
Vladimir Lerner, Beersheva Mental Health Center
  Purpose
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 (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

Further study details as provided by Vladimir Lerner, 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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750359


Locations
Israel
Tirat Carmel Mental Health Center
Tirat Carmel, Israel, 84170
Sponsors and Collaborators
Vladimir Lerner
Tirat Carmel Mental Health Center
Investigators
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
ClinicalTrials.gov Identifier: NCT01750359     History of Changes
Other Study ID Numbers: LBM-2010
IsraelMHC ( Other Identifier: Tirat Carmel &Be'er Sheva MHC )
First Submitted: July 25, 2012
First Posted: December 17, 2012
Last Update Posted: February 7, 2013
Last Verified: December 2012

Keywords provided by Vladimir Lerner, Beersheva Mental Health Center:
antioxidants
curcumin
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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