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Trial registered on ANZCTR


Registration number
ACTRN12617000155392
Ethics application status
Approved
Date submitted
25/01/2017
Date registered
30/01/2017
Date last updated
2/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Saffron for the treatment of adolescent depressive and anxiety symptoms – a randomised, double-blind, placebo-controlled study
Scientific title
Saffron for the treatment of adolescent depressive and anxiety symptoms – a randomised, double-blind, placebo-controlled study
Secondary ID [1] 290857 0
None
Universal Trial Number (UTN)
U1111-1191-4099
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 301541 0
Anxiety 301797 0
Condition category
Condition code
Mental Health 301260 301260 0 0
Depression
Mental Health 301261 301261 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Saffron capsules containing 14mg of a proprietary blend of saffron (affron 'Registered Trademark') will be consumed twice daily for 8 weeks by adolescents suffering from depressive and/or anxiety symptoms. Adherence to capsule intake will be monitored through capsule return and count.
Intervention code [1] 296799 0
Treatment: Other
Comparator / control treatment
Placebo is matched to the saffron capsules in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 300673 0
Change in mood symptoms as assessed by the Revised Child Anxiety and Depression Scale (RCADS) – self report scale (total internalising score & total anxiety score)
Timepoint [1] 300673 0
Weeks 0, 2, 4, 6 and 8
Secondary outcome [1] 330574 0
Change in mood symptoms as assessed by the Revised Child Anxiety and Depression Scale (RCADS) – parent version (total internalising score & total anxiety score)
Timepoint [1] 330574 0
Weeks 0, 2, 4, 6 and 8

Eligibility
Key inclusion criteria
1. Otherwise healthy males and females aged between 12 and 16 years
2. Child is suffering from mild-to-moderate depressive and/or anxiety symptoms as assessed by the RCADS (parent and child version)
3. Parents and child are fluent in English
4. Parent/legal guardian and child to provide a personally signed and dated informed consent indicating that they have been informed of all pertinent aspects of the trial.
5. Child willing and able to take prescribed placebo/saffron
Minimum age
12 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current or 12-month history in child of any psychiatric disorder other than mild-to-moderate depression or anxiety disorder.
2. Child is engaging in self-harm behaviours and/or experiencing thoughts of suicide
3. Child is currently taking any pharmaceutical medication, apart from the occasional use (no more than fortnightly) of pain-relievers (e.g., ibuprofen, Panadol)
4. Child is currently undertaking, or planning to commence during the duration of the study, psychological intervention for depression, anxiety or other mental health disorder.
5. Child is currently taking saffron supplements and/or other specific herbal products
6. Current or history of clinically significant chronic medical condition including cardiovascular disease, organic brain disorder, seizure, diabetes
7. Child currently abuses or is dependent on drugs
8. Child has any learning problem significantly affecting his/her educational achievement

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)
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 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 80) based on the order of inclusion in the study. A computer-generated software will randomly assign the numbers 1 to 80 into either group 1 or 2.
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 previous studies examining the antidepressants effects of saffron in adults, effects sizes of 1.5 have been observed.

If we assume a smaller effect size of 0.8, a sample size of 50 will be necessary. This gives an 80% chance of finding an effect at a statistical significance of 0.05. In this study will be using a sample size of 80, which should give us necessary power to find an effect, even after drop outs.

Pre and post analyses will be conducted to determine changes in the following:
1. Scores in the Revised Child Anxiety and Depression Scale (RCADS) (self-report)
2. Scores in the Revised Child Anxiety and Depression Scale (RCADS) (parent-report)

Comparisons will be made between the two conditions to determine if changes in symptoms are significantly different.

These analyses will be conducted via a repeated measures analysis of variance via SPSS

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 295288 0
Commercial sector/Industry
Name [1] 295288 0
Pharmactive
Address [1] 295288 0
Avda.Severo Ochoa, 37 – Local 4J
28108. Alcobendas. Madrid. Spain
Country [1] 295288 0
Spain
Primary sponsor type
University
Name
Murdoch University
Address
90 South St, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 294110 0
None
Name [1] 294110 0
Address [1] 294110 0
Country [1] 294110 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296623 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 296623 0
90 South St
Murdoch WA 6150
Ethics committee country [1] 296623 0
Australia
Date submitted for ethics approval [1] 296623 0
12/12/2016
Approval date [1] 296623 0
25/01/2017
Ethics approval number [1] 296623 0
2016/224

Summary
Brief summary
This is a double-blind, placebo-controlled study assessing the therapeutic effects of saffron in 80 youth suffering from depressive and/ anxiety symptoms. Participants will be randomly allocated into either a saffron (affron 'Registered Trademark' - 14mg twice daily) or placebo group and changes in symptoms will be measured over an 8-week period.
Trial website
Trial related presentations / publications
Lopresti AL, et al.. affron®, a standardised extract from saffron (Crocus sativus L.) for the treatment of youth anxiety and depressive symptoms: A randomised, double-blind, placebo-controlled study. J Affect Disord. 2018 May;232:349-357. doi: 10.1016/j.jad.2018.02.070. Epub 2018 Feb 26.
Public notes

Contacts
Principal investigator
Name 71510 0
Prof Peter Drummond
Address 71510 0
Murdoch University, School of Psychology and Exercise Science, 90 South St Murdoch Western Australia 6150
Country 71510 0
Australia
Phone 71510 0
+61 8 9360 2415
Fax 71510 0
Email 71510 0
P.Drummond@murdoch.edu.au
Contact person for public queries
Name 71511 0
Dr Adrian Lopresti
Address 71511 0
Murdoch University, School of Psychology and Exercise Science, 90 South St Murdoch Western Australia 6150
Country 71511 0
Australia
Phone 71511 0
+61411969797
Fax 71511 0
Email 71511 0
a.lopresti@murdoch.edu.au
Contact person for scientific queries
Name 71512 0
Dr Adrian Lopresti
Address 71512 0
Murdoch University, School of Psychology and Exercise Science, 90 South St Murdoch Western Australia 6150
Country 71512 0
Australia
Phone 71512 0
+61411969797
Fax 71512 0
Email 71512 0
a.lopresti@murdoch.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary