Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000791538
Ethics application status
Approved
Date submitted
18/07/2015
Date registered
30/07/2015
Date last updated
10/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the efficacy of curcumin and saffron for the treatment of depression
Scientific title
An evaluation of the efficacy of curcumin and saffron for the treatment of depression: a randomised, double-blind, placebo controlled-trial
Secondary ID [1] 286552 0
Nil
Universal Trial Number (UTN)
U1111-1169-4012
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 294799 0
Condition category
Condition code
Mental Health 295075 295075 0 0
Depression
Alternative and Complementary Medicine 295978 295978 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 with depression. Adherence to capsule intake will occur through records in a study diary and return of capsules.
Intervention code [1] 291658 0
Treatment: Other
Comparator / control treatment
Placebo is matched to to the curcumin/saffron capsules in terms of taste and appearance, but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 294838 0
Change in depression score as assessed by the Inventory of Depressive Symptomatology (IDS-SR30)
Timepoint [1] 294838 0
Weeks 0, 4, 8 and 12
Primary outcome [2] 294839 0
Change in anxiety levels as assessed by the Spielberger state-trait anxiety inventory (STAI)
Timepoint [2] 294839 0
Weeks 0, 4, 8 and 12
Secondary outcome [1] 314181 0
Change in blood and urinary biomarkers examining inflammation, e.g., CRP, kynurenine, kynurenic acid, pro-inflammatory cytokines.
Timepoint [1] 314181 0
Weeks 0 and 12
Secondary outcome [2] 316111 0
Change in blood and urinary biomarkers examining oxidative stress, e.g., malondialdehyde, 8-hydroxy-2' -deoxyguanosine.
Timepoint [2] 316111 0
Weeks 0 and 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will respond to advertisements and/or respond to flyers displayed in health clinics. Participants will then be briefly interviewed to assess eligibility and if meeting eligibility criteria a formal mental health assessment will be conducted (MINI International Neuropsychiatric interview). If the participant meet all eligibility criteria, he/she will be randomly allocated into a placebo, curcumin or curcumin/saffron treatment group. Group allocation will be conducted in a double-blind, randomised fashion. Allocation concealment will occur through the use of numbered containers where both the participant, and primary researcher responsible for conducting the study, will be unaware of its contents.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated into placebo and treatment groups. These groups are named group 1, group 2, group 3 and group 4. The primary investigator and participants will be unaware of which treatment these groups represent. Each participant will be allocated a participant number (1 to 120) based on order of inclusion in the study. A computer-generated software will randomly assign the numbers 1 to 160 into either group 1, 2, 3 or 4.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In a previous study completed by our research team, positive effects from curcumin were found when using a sample size of 60 adults. In previous trials on saffron, statistically significant effects were identified using samples of 40-60. Based on the the moderate effect sizes found in these studies and assuming a power of 80% and a type one error rate (alpha) of 5%, the number of participants per group to find a statistical effect is approximately 30. In the current study we will be using 40 participants per group

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/08/2015
Actual
19/08/2015
Date of last participant enrolment
Anticipated
31/03/2016
Actual
24/02/2016
Date of last data collection
Anticipated
Actual
26/02/2016
Sample size
Target
160
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 291116 0
Commercial sector/Industry
Name [1] 291116 0
Dolcas-Biotech, LLC
Country [1] 291116 0
United States of America
Primary sponsor type
University
Name
Murdoch University
Address
90 South St
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 289792 0
None
Name [1] 289792 0
Address [1] 289792 0
Country [1] 289792 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292697 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 292697 0
90 South St
Murdoch WA 6150
Ethics committee country [1] 292697 0
Australia
Date submitted for ethics approval [1] 292697 0
Approval date [1] 292697 0
11/12/2014
Ethics approval number [1] 292697 0
2014/241

Summary
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.
Trial website
Trial related presentations / publications
Lopresti, A.L. & Drummond, P.D. (2017) Efficacy of curcumin, and a saffron/curcumin combination for the treatment of major depression: A randomised, double-blind, placebo-controlled study. Journal of Affective Disorders, 207, 188-196.
Public notes

Contacts
Principal investigator
Name 56618 0
Prof Peter Drummond
Address 56618 0
Murdoch University, School of Psychology and Exercise Science, 90 South St Murdoch Western Australia 6150
Country 56618 0
Australia
Phone 56618 0
+61 8 9360 2415
Fax 56618 0
Email 56618 0
[email protected]
Contact person for public queries
Name 56619 0
Dr Adrian Lopresti
Address 56619 0
Murdoch University, School of Psychology and Exercise Science, 90 South St Murdoch Western Australia 6150
Country 56619 0
Australia
Phone 56619 0
+61411969797
Fax 56619 0
Email 56619 0
[email protected]
Contact person for scientific queries
Name 56620 0
Dr Adrian Lopresti
Address 56620 0
Murdoch University, School of Psychology and Exercise Science, 90 South St Murdoch Western Australia 6150
Country 56620 0
Australia
Phone 56620 0
+61411969797
Fax 56620 0
Email 56620 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of curcumin, and a saffron/curcumin combination for the treatment of major depression: A randomised, double-blind, placebo-controlled study.2017https://dx.doi.org/10.1016/j.jad.2016.09.047
N.B. These documents automatically identified may not have been verified by the study sponsor.