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Efficacy and Safety Curcumin in Depression

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ClinicalTrials.gov Identifier: NCT01750359
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : February 7, 2013
Sponsor:
Collaborator:
Tirat Carmel Mental Health Center
Information provided by (Responsible Party):
Vladimir Lerner, Beersheva Mental Health Center

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.

Condition or disease Intervention/treatment Phase
Major Depression Drug: curcumin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : August 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Active Comparator: curcumin Drug: curcumin
500 mg/day for 6 week

Placebo Comparator: placebo Drug: curcumin
500 mg/day for 6 week




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older 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


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

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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 Posted: December 17, 2012    Key Record Dates
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:
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Depression
Depressive Disorder
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