Ranquilon in anxiety associated with neurasthenia and adjustment disorder: randomized double-blind placebo-controlled phase III trial
T. A. Karavayeva, E. M. Krupitsky, A. N. Barinov, L. G. Kolik, K. A. Ishchenko, K. K. Khacheva · 2024 · V.M. Bekhterev Review of Psychiatry and Medical Psychology. 58(4-2):78–99
Reported findings and study design
At day 29, 77/110 (70.0%) Ranquilon recipients achieved at least a 50% HARS anxiety-score reduction versus 27/110 (24.5%) on placebo (p<0.0001). The reported response-rate difference was 45.5 percentage points.
Dose, route and schedule
Ranquilon 6 mg/day orally (2 mg three times daily) or matching placebo for 28 days. Study methods, not a recommended personal regimen.
Protocol source ↗ · Original 22-page journal PDF: methods, bilingual summary and selected numerical results checked.
| Measure | Result | Comparison, timing and statistics |
|---|---|---|
| Primary ≥50% HARS response | 77/110 (70.0%) versus 27/110 (24.5%) | Day 29 ± 1 · p<0.0001 |
| Response-rate difference | 45.5 percentage points | Absolute difference, not a 45.5% relative reduction |
| HARS decrease · day 29 | 11.90 ± 4.88 versus 5.43 ± 5.03 points | p<0.0001 |
| Patients with adverse events | 28/110 (25.5%) versus 16/110 (14.6%) | p=0.063 |
| Adverse-event counts | 43 active-arm events; 21 placebo-arm events | No serious events or adverse-event discontinuations reported |
Phase III reported comparisons
| Endpoint | Ranquilon (n=110) | Placebo (n=110) | Comparison |
|---|---|---|---|
| HARS response ≥50%, day 15 | 32 (29.1%) | 6 (5.5%) | p<0.0001 |
| HARS response ≥50%, day 29 | 77 (70.0%) | 27 (24.5%) | p<0.0001 |
| HARS decrease, day 15 | 7.47 ± 5.11 | 2.91 ± 3.04 | p<0.0001 |
| HARS decrease, day 29 | 11.90 ± 4.88 | 5.43 ± 5.03 | p<0.0001 |
| Patients with adverse events | 28 (25.5%) | 16 (14.6%) | p=0.063 |
HARS decreases are mean ± SD points. Response and adverse-event denominators are patients; event totals are separate.
Neurasthenia and adjustment disorders; do not relabel this as a generalized-anxiety-disorder trial. Valenta-funded report with sponsor-affiliated authors; 28-day efficacy and safety require longer independent follow-up.
Source for the extracted data ↗ · Checked 2026-11-01
Molekul summary of the linked publication. Educational information, not medical advice. Seek qualified healthcare help for medical conditions.
Methods, limitations & source review
Study limitations
- Neurasthenia and adjustment disorders; do not relabel this as a generalized-anxiety-disorder trial.
- Valenta-funded report with sponsor-affiliated authors; 28-day efficacy and safety require longer independent follow-up.
Publication counts are not counts of independent trials. Reviews, translations and reports sharing participants may overlap. Findings apply to the studied preparation, population and endpoints.
Review depth: Original 22-page journal PDF: methods, bilingual summary and selected numerical results checked.
Related-report group: gb115-phase3-NCT05586789. Reports in this group are not assumed to be independent trials.
Source access and review scope
Original 22-page journal PDF: methods, bilingual summary and selected numerical results checked.
Recorded source-check date: 2026-11-01. This date does not imply a completed systematic review.
Source type: Original journal publication
Citation and original source
Original source: T. A. Karavayeva, E. M. Krupitsky, A. N. Barinov, L. G. Kolik, K. A. Ishchenko, K. K. Khacheva. Ranquilon in anxiety associated with neurasthenia and adjustment disorder: randomized double-blind placebo-controlled phase III trial V.M. Bekhterev Review of Psychiatry and Medical Psychology. 58(4-2):78–99 2024.
Molekul research summary: https://molekul.io/research/gb115-phase3-2024. Cite the original publication for its findings and this page when referring to Molekul’s summary or evidence appraisal.
Bibliography entry