Major DepressionPhase 4NCT01750359

Efficacy and Safety Curcumin in Depression

A Phase 4 study testing curcumin in people with Major Depression, run by Vladimir Lerner at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Major Depression
What is being tested?: curcumin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteIsrael
Study dates: Aug 2010to Jun 2011
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Israel1 site

Tirat Carmel Mental Health Center
Tirat Carmel, 84170

Other trials in Israel

About this study

Official title: The Efficacy and Safety of Adjunctive Curcumin for Treatment of Depression: A Randomized, Double-blind, Placebo-controlled Study

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
Being tested: curcumin
Keywords: antioxidants, curcumin, depression
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

curcuminDrug
500 mg/day for 6 week

Study groups in NCT01750359
Study group	Role	What they receive
curcumin	Active comparator	Not described Receives: Drug: curcumin
placebo	Placebo comparator	Not described Receives: Drug: curcumin

What is being measured

The primary outcome is the main question the study is designed to answer.

Hamilton Depression Rating Scale
Measured: Change in the scores from baseline at six weeks
Montgomery-Asberg Depression Rating Scale
Measured: Change in the scores from baseline at six weeks

Secondary outcomes (1)

Clinical Global Impression
Measured: Change in the scores from baseline at six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Jun 2011

First posted17 Dec 2012 (estimated)
Study startAug 2010
Primary completionMay 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Major DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01750359
Sponsor's protocol ID: LBM-2010
Other IDs: IsraelMHC
Status last verified: Dec 2012
First submitted: 25 Jul 2012
Last updated: 7 Feb 2013
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
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Digital Intervention for Physical Activity
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Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
RecruitingPhase 3
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
Major Depressive Disorder (MDD), Depression in Adults

All Major Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Safety of Adjunctive Curcumin for Treatment of Depression: A Randomized, Double-blind, Placebo-controlled Study
ClinicalTrials.gov ID: NCT01750359
Acronym / sponsor ID: LBM-2010
Conditions: Major Depression
Keywords: antioxidants, curcumin, depression
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Vladimir LernerOther government
Collaborators: Tirat Carmel Mental Health Center
Study start: Aug 2010
Primary completion: May 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 17 Dec 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
curcumin	Active comparator	Drug: curcumin
placebo	Placebo comparator	Drug: curcumin

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (8 listed)

Evidence of organic brain damage
Mental retardation
Alcohol or drug abuse
An unstable medical condition
Any significant medical or neurological illness

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
curcumin500 mg/day for 6 week	Drug	curcumin, placebo

Primary outcome

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

1 secondary outcome

Clinical Global Impression
Time frame: Change in the scores from baseline at six weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.

Related trials for Major Depression

RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
Recruiting
Digital Intervention for Physical Activity
Depression - Major Depressive Disorder, Anxiety
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
RecruitingPhase 3
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
Major Depressive Disorder (MDD), Depression in Adults

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joseph Bergman, MD principal investigator

Tirat Carmel

Vladimir Lerner, MD, PhD study director

Beersheva Mental Health Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing curcumin in people with Major Depression, run by Vladimir Lerner at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Depression Rating Scale (time frame: Change in the scores from baseline at six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01750359.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2013; AzTrials last refreshed its copy on 30 Oct 2026.