- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01750359
Efficacy and Safety Curcumin in Depression
The Efficacy and Safety of Adjunctive Curcumin for Treatment of Depression: A Randomized, Double-blind, Placebo-controlled Study
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Tirat Carmel, Israel, 84170
- Tirat Carmel Mental Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
500 mg/day for 6 week
|
Active Comparator: curcumin
|
500 mg/day for 6 week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hamilton Depression Rating Scale
Time Frame: Change in the scores from baseline at six weeks
|
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
|
Change in the scores from baseline at six weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical Global Impression
Time Frame: Change in the scores from baseline at six weeks
|
Change in the scores from baseline at six weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph Bergman, MD, Tirat Carmel
- Study Director: Vladimir Lerner, MD, PhD, Beersheva Mental Health Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- LBM-2010
- IsraelMHC (Other Identifier: Tirat Carmel &Be'er Sheva MHC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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