Clinical trial NCT01750359: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depression
Keywords: antioxidants
curcumin
depression
Lead sponsor: Beersheva Mental Health Center
Sponsor class: OTHER_GOV
Collaborators: name: Tirat Carmel Mental Health Center
First posted: 2012-12-17
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: Change in the scores from baseline at six weeks
measure: Montgomery-Asberg Depression Rating Scale
timeFrame: Change in the scores from baseline at six weeks
Secondary outcomes:
measure: Clinical Global Impression
timeFrame: Change in the scores from baseline at six weeks
Other outcomes:
Locations:
city: Tirat Carmel
country: Israel
facility: Tirat Carmel Mental Health Center
Study officials:
affiliation: Tirat Carmel
name: Joseph Bergman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beersheva Mental Health Center
name: Vladimir Lerner, MD, PhD
role: STUDY_DIRECTOR
References: