Efficacy of saffron as an adjunct treatment for unremitted depression in adults

Not Applicable

Completed

• Conditions: Depression; Mental Health - Depression

• Registration Number: ACTRN12618000748213
• Lead Sponsor: Murdoch University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-04
• Study Completion: 2019-01-11
• Last Update Posted: 30 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mood symptoms as assessed by – Montgomery–Åsberg Depression Rating Scale (Clinician-Rated) (MADRS)[Weeks 0, 4 and 8 (week 8 is primary endpoint)];Change in mood symptoms as assessed by – Montgomery–Åsberg Depression Rating Scale (Self-Rated) (MADRS-S)[Weeks 0, 4 and 8 (week 8 is primary endpoint)]

Secondary Outcome Measures

Name	Time	Method
Change in quality of life and general health (composite secondary outcome) as assessed by the Short Form-36 Health Survey (SF-36).[Weeks 0, 4 and 8];Difference in adverse effects (e.g., constipation, diarrhoea, problems with sexual function, headache) as assessed by the Antidepressant Side-Effect Checklist (ASEC).[Weeks 0, 4 and 8]