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Trial record 2 of 158 for:    Enzyme | curcumin

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

Tracking Information
First Submitted Date  ICMJE July 25, 2012
First Posted Date  ICMJE December 17, 2012
Last Update Posted Date February 7, 2013
Study Start Date  ICMJE August 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2012)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01750359 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2012)
Clinical Global Impression [ Time Frame: Change in the scores from baseline at six weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2012)
CGI [ Time Frame: Change in the scores from baseline at six weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Curcumin in Depression
Official Title  ICMJE The Efficacy and Safety of Adjunctive Curcumin for Treatment of Depression: A Randomized, Double-blind, Placebo-controlled Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Major Depression
Intervention  ICMJE Drug: curcumin
500 mg/day for 6 week
Study Arms  ICMJE
  • Active Comparator: curcumin
    Intervention: Drug: curcumin
  • Placebo Comparator: placebo
    Intervention: Drug: curcumin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2012)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01750359
Other Study ID Numbers  ICMJE LBM-2010
IsraelMHC ( Other Identifier: Tirat Carmel &Be'er Sheva MHC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vladimir Lerner, Beersheva Mental Health Center
Study Sponsor  ICMJE Vladimir Lerner
Collaborators  ICMJE Tirat Carmel Mental Health Center
Investigators  ICMJE
Principal Investigator: Joseph Bergman, MD Tirat Carmel
Study Director: Vladimir Lerner, MD, PhD Beersheva Mental Health Center
PRS Account Beersheva Mental Health Center
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP