Antidepressant, antioxidant and anti-inflammatory effects of curcumin in adults diagnosed with major depression

Antidepressant, antioxidant and anti-inflammatory effects of curcumin in adults diagnosed with major depression: A randomised, double-blind, placebo controlled study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001260819

Enrollment

Registered

2012-12-03

Start date

2013-01-14

Completion date

2013-11-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a double-blind, placebo controlled study assessing the antidepressant, antioxidant and anti-inflammatory effects of curcumin in 60 adults suffering from major depression (mild to moderate severity). Participants will be randomly allocated into either a curcumin (BCM-95 'Registered Trademark' - 500mg twice daily) or placebo group and changes in depression, anxiety and general health will be measured over an 8-week period. The aim of this study is also to investigate potential mechanisms of action of curcumin so urine, saliva and blood samples will be collected at the beginning and completion of the study. Levels of cortisol, kynurenine pathway metabolites (measure of inflammation) and oxidative stress markers will be assessed over time.

Interventions

Curcumin capsules containing 500mg of a proprietry blend of curcumin (BCM-95 'Registered Trademark') will be consumed twice daily for 8 weeks by adults diagnosed with major depression.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Male or female aged between 18 and 65 years 2. Suffering from major depression (mild to moderate severity) as assesed by the Mini International Neuropsychiatric interview 3. Medication-free for at least 4 months (except pharmaceutical antidepressants and contraceptive pill) 4. Non-smoker

Exclusion criteria

1. Suffer from a diagnosable mental health disorder other than depression e.g., eating disorder, psychosis/ schizophrenia. 2. Suffer from medical illnesses including diabetes, autoimmune diseases, cardiovascular disease, hypertension, chronic fatigue syndrome, asthma. 3. Pregnant or intend to fall pregnant 4. Currently breastfeeding 5. Have suffered from an infection or illness over the last month (includes the common cold) 6. Currently take any antiplatelet (e.g., Aspirin, non-steroidal anti-inflammatories, clopidogrel, dipyridamole, abciximab, tirofiban) and anticoagulant medications (e.g., Warfarin, rivaroxaban, dabigatran etexilate) 7. Have been diagnosed with any coagulation disorder such as Haemophilia, Thrombocytopenia, Von Willebrand's disease and Hypoprothrombinemia. 8. Suffer from a recent history of severe bruising, excessive bleeding following an injury, abnormal blood count (including platelets counts), profuse nosebleeds, and excessively prolonged or heavy menstrual bleeding

Outcome results