None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 160 adults who are currently taking an antidepressant medication but continue to suffer from depressive symptoms (mild-to-moderate severity) will be randomly assigned to receive tablets containing either a saffron extract (28mg a day) or placebo for 8 weeks. Participants recruited for this study will be on a stable medication dose for at least 8-weeks and will have no plan to change the dosage or medication type during the study. We will assess change in depressive symptoms via a validated clinician-rated instrument and a self-report measure (to be completed every 4 weeks). We will also assess whether saffron is able to reduce some of the side effects associated with antidepressant drug use (in 2 studies it has previously shown to reduce sexually-related side effects).
Interventions
Two tablets containing 14mg of a proprietary saffron extract (affron) (total daily dose of 28mg) will be consumed twice daily for 8 weeks by adults aged between 18 and 65 years. Participants will already be on a stable dose (at least 8 weeks) of a single pharmaceutical antidepressant but continues to suffer from mild-to-moderate depression. Adherence to capsule intake will be monitored through capsule return and count.
Sponsors
Murdoch University
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
No
Inclusion criteria
1. Adults (male and female) aged between 18 and 65 years 2. Currently taking a stable dose (at least 8 weeks) of a single pharmaceutical antidepressant (SSRI or SNRI) 3. Despite antidepressant treatment, continues to suffer from mild-to-moderate depression as assessed by a validated measure 4. Fluent in English 5. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial. 6. Willing and able to take prescribed placebo/saffron
Exclusion criteria
1. DSM-5 diagnoses other than major depression, including but not limited to bipolar disorder, anxiety disorders, schizophrenia, psycho-organic syndromes, eating disorders, substance abuse or dependence disorders. 2. At significant risk of suicide or engaging in self-harm behaviours 3. Pregnant women, women who are breastfeeding or women who intended to fall pregnant. 4. Suffering from major medical illness, including neurodegenerative /neuroinflammatory disorders, such as Alzheimer’s disease, stroke, Parkinson’s disease or multiple sclerosis; autoimmune disorders, diabetes, inflammatory bowel disease, COPD, etc. 5. Currently taking medications including, but not limited to glucocorticoids, antibiotics, and anticoagulant medications. Use of analgesics (once a week) or contraceptive pills are permissible. 6. Currently taking saffron supplements and/or other specific herbal products, including omega-3 fatty acids. 7. Greater than 10-year history of depression
Outcome results
None listed