A randomised placebo-controlled trial examining the efficacy and safety of an adjunct herbal medicine formulation in patients with major depressive disorder and poor response to anti-depressant therapy

Not Applicable

• Conditions: Depression; Anxiety; Mental Health - Depression; Mental Health - Anxiety

• Registration Number: ACTRN12622000777796
• Lead Sponsor: Integria Healthcare (Australia) Pty. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-31
• Study Completion: 2023-11-10
• Last Update Posted: 11 March 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified