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Efficacy and Safety Curcumin in Depression

Primary Purpose

Major Depression

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
curcumin
Sponsored by
Vladimir Lerner
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring antioxidants, curcumin, depression

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tirat Carmel Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

curcumin

placebo

Arm Description

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale
Montgomery-Asberg Depression Rating Scale

Secondary Outcome Measures

Clinical Global Impression

Full Information

First Posted
July 25, 2012
Last Updated
February 6, 2013
Sponsor
Vladimir Lerner
Collaborators
Tirat Carmel Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT01750359
Brief Title
Efficacy and Safety Curcumin in Depression
Official Title
The Efficacy and Safety of Adjunctive Curcumin for Treatment of Depression: A Randomized, Double-blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vladimir Lerner
Collaborators
Tirat Carmel Mental Health Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
antioxidants, curcumin, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
curcumin
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
curcumin
Intervention Description
500 mg/day for 6 week
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Time Frame
Change in the scores from baseline at six weeks
Title
Montgomery-Asberg Depression Rating Scale
Time Frame
Change in the scores from baseline at six weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impression
Time Frame
Change in the scores from baseline at six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Bergman, MD
Organizational Affiliation
Tirat Carmel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vladimir Lerner, MD, PhD
Organizational Affiliation
Beersheva Mental Health Center
Official's Role
Study Director
Facility Information:
Facility Name
Tirat Carmel Mental Health Center
City
Tirat Carmel
ZIP/Postal Code
84170
Country
Israel

12. IPD Sharing Statement

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Efficacy and Safety Curcumin in Depression

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