None listed
Conditions
Brief summary
Anti-depressants are a commonly used medication in Australia, with over 15 million prescriptions dispensed in 2018-2019 (Australian Institute of Health and Welfare 2019). However, the response to anti-depressants is varied, and some patients experience flatline emotion, ongoing depression, decreased cognition, changes in sexual function/desire, insomnia, and other symptoms. Selective serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed first-line treatment for major depression, however, the rate of treatment response from baseline symptoms following first-line treatment with SSRIs is moderate, varying from 40-60% and lower in subsequent treatment attempts. There is evidence that inflammatory cytokines contribute to the development of depression in both medically ill and medically healthy individuals (Felger and Lotrich 2013), and research supporting anti-inflammatory approaches to depression management has been shown to increase effectiveness of some anti-depressants in clinical trials (Muller, Schwarz et al. 2006, Akhondzadeh, Jafari et al. 2009, Hang, Zhang et al. 2021). Given the large proportion of patients who do not respond adequately to first-line therapy, or experience negative side-effects, incorporating adjunct treatments may need to be considered. Certain herbal medicines may be able to assist treatment response by decreasing inflammation and reducing side effects. It is hypothesised that specific anti-inflammatory and anti-depressant herbs may effect a clinically meaningful improvement when added as an adjunct to existing anti-depressants in patients with poor response to anti-depressant therapy.
Interventions
Participants enrolled in the trial will receive either Active tablets or Placebo tablets as an adjunct prescription to their existing anti-depressant medication. Participants will be directed to take two tablets, orally, twice daily, two in the morning and two in the evening (total of 4 tablets per day).
All participants will be randomised to either Active or Placebo study medication for eight weeks.
- Active Tablets contain four concentrated herbal extracts (dry herb equivalent): Curcuma long
Participants enrolled in the trial will receive either Active tablets or Placebo tablets as an adjunct prescription to their existing anti-depressant medication. Participants will be directed to take two tablets, orally, twice daily, two in the morning and two in the evening (total of 4 tablets per day). All participants will be randomised to either Active or Placebo study medication for eight weeks. - Active Tablets contain four concentrated herbal extracts (dry herb equivalent): Curcuma longa rhizome (6.4 g), Boswellia serrata resin (1.5 g), Bupleurum falcatum root (750 mg), and Centella asiatica leaf (1.5 g). Compliance will be assessed through count of return tablets.
Sponsors
Integria Healthcare (Australia) Pty. Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
- Adults (18-65 years) with previously diagnosed depression - Presents with moderate to severe depression BDI-II score >20 at time of study entry - Currently taking one of the following anti-depressant types: SSRI, SNRI, alpha-2 agonists (mirtazapine), or bupropion.
Exclusion criteria
- Concomitant diagnosis of other DSM-IV mental disorder including but not limited to: personality disorder, substance-related or addictive disorders, bipolar disorder, schizophrenia; or any other neuro-cognitive disorders - Diagnosed with any of the following medical conditions: cancer (if active within last 10 years), liver or gallbladder disease, kidney disease, neurological disease, advanced type-2 diabetic neuropathy, currently unwell with acute infection or fever - Abnormal laboratory values (clinically significant abnormal values will result in exclusion) - In poor general health - Taking any of the following medications: MAOIs (reversible or non-reversible) or tricyclic anti-depressants; any type of neuro-active medications, i.e. mood stabilisers, stimulants, anti-psychotics; warfarin, anti-platelet or anti-coagulant medications; talinolol - Current use of specified complementary medicines including, but not limited to; St John’s wort, SAMe, 5-HTP, folic acid >500 mcg/d, omega-3 containing >180 mg EPA/d, zinc >15 mg/d (in such cases a four week washout can be employed before re-screening and potential inclusion) - Change in anti-depressant medication or dose within the previous four weeks - Patients with suicidal ideation (4 or higher on MADRS suicidal thoughts domain) at time of study entry - Three or more failed trials of pharmacotherapy or somatic therapy for the current major depressive episode - More than ten years of medicated major depressive disorder in current episode - Recently commenced psychotherapy (>4 weeks of stable treatment acceptable) - Pregnancy or breastfeeding or planned pregnancy - Allergy/sensitivity to study drugs or their formulations.
Outcome results
None listed