Comparing Amantadine, Pramipexole, and Quetiapine for Treatment-Resistant Depression
Comparative Efficacy of Antidepressant Augmentation With Amantadine vs Pramipexole vs Quetiapine in Treatment-resistant Unipolar Depression: A Randomized Controlled Trial.
This study is testing whether adding Amantadine, Pramipexole, or Quetiapine to the usual antidepressant Sertraline can help people with treatment-resistant depression feel better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences, Bhubaneswar Academic / other |
| Locations | 1 site (Bhubaneswar, Orissa) |
| Trial ID | NCT04936126 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of three different medications—Amantadine, Pramipexole, and Quetiapine—as augmentations to SSRIs in patients with treatment-resistant depression (TRD). The study will involve 150 patients who are currently on Sertraline and will assess changes in depression severity using the Hamilton Depression Scale over an 8-week period. Additionally, the trial will measure serum levels of Brain-derived neurotrophic factor (BDNF) and Nerve growth factor (NGF) to explore their correlation with treatment outcomes. The study is designed as a prospective, randomized, single-blind, controlled trial conducted over three years.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with unipolar treatment-resistant depression currently on Sertraline.
Not a fit: Patients with bipolar disorder, those on antidepressants other than Sertraline, or individuals with significant co-morbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new effective treatment options for patients suffering from treatment-resistant depression.
How similar studies have performed: While there have been studies on antidepressant augmentation, this specific comparison of Amantadine, Pramipexole, and Quetiapine in TRD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with unipolar depression clinically diagnosed as TRD, who are currently on Sertraline treatment (dose range = 100-200 mg/day) 2. Patients aged 18-60 years of either sex Exclusion Criteria: 1. Patients with Bipolar affective disorder 2. Patient with TRD on antidepressants other than Sertraline 3. History of psychoactive substance abuse or dependence 4. Co-morbid psychiatric, major medical, or neurological disorders 5. History of organicity or significant head injury 6. Pregnant and lactating women
Where this trial is running
Bhubaneswar, Orissa
- All India Institute of Medical Sciences — Bhubaneswar, Orissa, India (Recruiting)
Study contacts
- Study coordinator: Biswa R Mishra, MD, DPM
- Email: brm1678@gmail.com
- Phone: 9438884220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.