Ranquilon dose-finding in anxiety associated with neurasthenia and adjustment disorders: phase II trial
O. V. Goncharov, D. Ch. Mavani, A. A. Ledovskikh, L. A. Tsukurova, M. M. Gavrik, I. V. Balaban, A. A. Globenko, A. V. Kapashin, M. A. Pasko · 2023 · Clinical Pharmacology and Therapy. 32(4):36–40
Reported findings and study design
At day 29, marked or substantial clinician-rated improvement occurred in 57.1% at 6 mg/day versus 28.6% with placebo (p=0.0148). The 3 mg and 9 mg groups did not significantly outperform placebo on that primary endpoint.
Dose, route and schedule
Oral 3, 6 or 9 mg/day, split three times daily, or matching placebo for 28 days. Study methods, not a recommended personal regimen.
Protocol source ↗ · Publisher full-text HTML methods and results checked.
| Measure | Result | Comparison, timing and statistics |
|---|---|---|
| Primary CGI-I response · 6 mg/day | 57.1% versus 28.6% placebo | Day 29 · p=0.0148 |
| Primary CGI-I response · 3 / 9 mg/day | 39.5% / 43.9% | Neither significantly exceeded placebo |
| Analysis populations | 168 intention-to-treat; 165 per protocol |
Phase II primary CGI-I response
| Group | Randomized | ITT response | PP response |
|---|---|---|---|
| 3 mg/day | 43 | 39.5% | 40.5% |
| 6 mg/day | 42 | 57.1% | 58.5% |
| 9 mg/day | 41 | 43.9% | 45.0% |
| Placebo | 42 | 28.6% | 28.6% |
Response: CGI-I 1 or 2 at day 29. ITT n=168; PP n=165. Only the 6 mg/day comparison reached significance versus placebo.
Randomized double-blind study in neurasthenia/adjustment disorders; generalized anxiety disorder was excluded. Sponsor-affiliated investigators; four-week findings do not establish long-term benefit.
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
- Randomized double-blind study in neurasthenia/adjustment disorders; generalized anxiety disorder was excluded.
- Sponsor-affiliated investigators; four-week findings do not establish long-term benefit.
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: Publisher full-text HTML methods and results checked.
Source access and review scope
Publisher full-text HTML methods and 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: O. V. Goncharov, D. Ch. Mavani, A. A. Ledovskikh, L. A. Tsukurova, M. M. Gavrik, I. V. Balaban, A. A. Globenko, A. V. Kapashin, M. A. Pasko. Ranquilon dose-finding in anxiety associated with neurasthenia and adjustment disorders: phase II trial Clinical Pharmacology and Therapy. 32(4):36–40 2023.
Molekul research summary: https://molekul.io/research/gb115-phase2-2023. Cite the original publication for its findings and this page when referring to Molekul’s summary or evidence appraisal.
Bibliography entry