Saffron for the treatment of adolescent depressive and anxiety symptoms – a randomised, double-blind, placebo-controlled study

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000155392

Enrollment

Registered

2017-01-30

Start date

2017-02-28

Completion date

2017-06-16

Last updated

2018-06-11

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 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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

12 Years to 16 Years

Healthy volunteers

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

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

Outcome results