Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001260819
Ethics application status
Approved
Date submitted
30/11/2012
Date registered
3/12/2012
Date last updated
11/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Antidepressant, antioxidant and anti-inflammatory effects of curcumin in adults diagnosed with major depression
Scientific title
Antidepressant, antioxidant and anti-inflammatory effects of curcumin in adults diagnosed with major depression: A randomised, double-blind, placebo controlled study
Secondary ID [1] 281604 0
Nil
Universal Trial Number (UTN)
U1111-1137-5069
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 287887 0
Condition category
Condition code
Mental Health 288265 288265 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 286140 0
Treatment: Other
Comparator / control treatment
Placebo, is matched to to the curcumin capsules in terms of taste and appearance, but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 288440 0
Change in depression score as assessed by the Inventory of Depressive Symptomatology (IDS-SR30)
Timepoint [1] 288440 0
Weeks 1, 4 and 8
Primary outcome [2] 288441 0
Change in anxiety levels as assessed by the Spielberger state-trait anxiety inventory (STAI)
Timepoint [2] 288441 0
Weeks 1, 4 and 8
Primary outcome [3] 288442 0
Change in general health as assessed by SF-36 Health Survey
Timepoint [3] 288442 0
Weeks 1, 4 and 8
Secondary outcome [1] 300170 0
Change in salivary cortisol awakening response
Timepoint [1] 300170 0
Weeks 1 and 8
Secondary outcome [2] 300171 0
Changes in inflammatory and oxidative stress markers as assed in blood and urine
Timepoint [2] 300171 0
Weeks 1 and 8

Eligibility
Key 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
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)
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

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 or curcumin treatment group. Group allocation will be conducted in a double-blind, randomised fashion.
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 and group 2 and the primary investigator and participants will be unaware of which treatment these groups represent. Each participant will be allocated a participant number (1 to 60) based on order of inclusion in the study. A computer-generated software will randomly assign the numbers 1 to 60 into either group 1 or 2.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2013
Actual
14/01/2013
Date of last participant enrolment
Anticipated
Actual
1/11/2013
Date of last data collection
Anticipated
Actual
28/12/2013
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 286415 0
Commercial sector/Industry
Name [1] 286415 0
Arjuna Natural Extracts Ltd.
Country [1] 286415 0
India
Primary sponsor type
University
Name
Murdoch University
Address
90 South St
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 285197 0
None
Name [1] 285197 0
Address [1] 285197 0
Country [1] 285197 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288490 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 288490 0
Ethics committee country [1] 288490 0
Australia
Date submitted for ethics approval [1] 288490 0
Approval date [1] 288490 0
23/11/2012
Ethics approval number [1] 288490 0
2012/205

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34999 0
Prof Peter Drummond
Address 34999 0
Murdoch University, 90 South St Murdoch Western Australia 6150
Country 34999 0
Australia
Phone 34999 0
+61, 08, 9360 6000
Fax 34999 0
Email 34999 0
[email protected]
Contact person for public queries
Name 18246 0
Adrian Lopresti
Address 18246 0
4/ 165 Summerlakes Pde
Ballajura WA 6066
Country 18246 0
Australia
Phone 18246 0
+61 08 9248 6904
Fax 18246 0
+61 08 9248 4274
Email 18246 0
[email protected]
Contact person for scientific queries
Name 9174 0
Adrian Lopresti
Address 9174 0
4/ 165 Summerlakes Pde
Ballajura WA 6066
Country 9174 0
Australia
Phone 9174 0
+61 08 9248 6904
Fax 9174 0
+61 08 9248 4274
Email 9174 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
No additional documents have been identified.