ACTRN12622000777796Terminated未知
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
Integria Healthcare (Australia) Pty. Ltd.0 sites96 target enrollmentStarted: May 31, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Terminated
- Sponsor
- Enrollment
- 96
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- All
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.
Investigators
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