Efficacy and Safety Curcumin in Depression

NCT01750359 | Completed Phase 4 DMC

• 2 other identifiers: LBM-2010IsraelMHC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression

Keywords

antioxidants; curcumin; depression

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Rating Scale

  Change in the scores from baseline at six weeks

• Montgomery-Asberg Depression Rating Scale

  Change in the scores from baseline at six weeks

Secondary Outcomes (1)

• Clinical Global Impression

  Change in the scores from baseline at six weeks

Study Arms (2)

curcumin

ACTIVE COMPARATOR

Drug: curcumin

placebo

PLACEBO COMPARATOR

Drug: curcumin

Interventions

curcumin DRUG

500 mg/day for 6 week

curcumin; placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vladimir Lerner: lead
• Tirat Carmel Mental Health Center: collaborator

Study Sites (1)

Tirat Carmel Mental Health Center

Tirat Carmel, 84170, Israel

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Joseph Bergman, MD

  Tirat Carmel

  PRINCIPAL INVESTIGATOR

• Vladimir Lerner, MD, PhD

  Beersheva Mental Health Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: A/Professor, Head of department

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: December 17, 2012
• Study Start: August 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 7, 2013

Record last verified: 2012-12

Locations

IL (1)