An evaluation of the efficacy of curcumin and saffron for the treatment of depression

An evaluation of the efficacy of curcumin and saffron for the treatment of depression: a randomised, double-blind, placebo controlled-trial

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000791538

Enrollment

160

Registered

2015-07-30

Start date

2015-08-19

Completion date

2016-02-24

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 effects of curcumin or curcumin/saffron in 160 adults suffering from depression (mild to moderate severity). Participants will be randomly allocated into one of four groups (1) curcumin (BCM-95 'Registered Trademark' - 250mg twice daily); (2) curcumin/ saffron (BCM-95 'Registered Trademark' - 250mg + 15mg saffron twice daily); (3) curcumin (BCM-95 'Registered Trademark' - 500mg twice daily); (4) placebo. Changes in depression and anxiety will be measured over a 12-week period. The aim of this study is also to investigate potential mechanisms of action of curcumin so urine and blood samples will be collected at the beginning and completion of the study. Levels of markers associated with inflammation and oxidative stress will be assessed over time.

Interventions

Participants will be randomly allocated into one of three intervention groups: (1) curcumin capsules containing 250mg of a proprietary blend of curcumin (BCM-95 'Registered Trademark'); (2) curcumin capsules containing 250mg of a proprietary blend of curcumin (BCM-95 'Registered Trademark') plus 15mg of saffron; or (3) curcumin capsules containing 500mg of a proprietary blend of curcumin (BCM-95 'Registered Trademark'). These capsules will be consumed twice daily for 12 weeks by adults diagnosed

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

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 depression (mild to moderate severity) as assesed by the Mini International Neuropsychiatric interview 3. Medication-free for at least 3 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)

Outcome results