§1 · How to Read the Tiers
Three weights of evidence
Clinical — human trial data (the 2009 placebo-controlled neurasthenia study and the 2010 multicentre study of 728 patients). Animal — controlled animal experiments, largely from the Zakusov Institute tradition. Review — conclusions of the peer-reviewed English-language actoprotector review over the Russian literature. Human efficacy claims on this site rest only on the clinical tier; everything else is labelled as the lower tier it is.
§2 · The Clinical Core
Established in human trials
Anti-fatigue / anti-asthenia action
Clinical
The strongest claim in the record. In the 728-patient, 28-centre Russian multicentre trial, ladasten at 50–100 mg/day for 28 days produced improvement from day 3 that persisted for a month after treatment ended; responder rates reached 76.0% on CGI-S and 90.8% on CGI-I. Sleep–wake normalisation was also observed in this cohort.
Voznesenskaia et al. 2010 · PMID 21322821
Neurasthenia relief with anxiolytic action — without sedation
Clinical
In the placebo-controlled trial, ladasten was superior to placebo in both the rate and the degree of asthenia-symptom reduction, combining psychostimulant and anxiolytic action in one profile — while lacking hypno-sedative and muscle-relaxant properties. Calm without dullness; activation without tension.
Neznamov et al. 2009 · PMID 19491814
No dependence, no tolerance, no withdrawal
Clinical Animal
No withdrawal syndrome appeared after discontinuation in the clinical trial, and chronic animal administration showed no dependence or tolerance — consistent with the actoprotector class definition of non-exhaustive action: no hyperstimulation during the effect, no debt after it.
Neznamov et al. 2009 · Iezhitsa et al. 2000 (PMID 11109517) · review PMID 24009833
§3 · The Performance Envelope
Documented in animal and field literature
Physical endurance and work capacity
Animal
Across the 0.5–50 mg/kg range, bromantane exceeded the effect of phenamine (amphetamine) by a factor of 1.3–1.6 in mouse swimming and rat treadmill tests — more work, achieved through synthesis support rather than forced release.
Morozov & Kleimenova 1998 · PMID 9929819
Performance in heat and hypoxia
Animal Review
Thermoprotective effects during overheating were documented experimentally (Badyshtov 1995), and the actoprotector review reports recovery support under hypoxia and hyperthermia — the exact "complicated conditions" the Zakusov Institute designed for.
Badyshtov 1995 · PMID 7793100 · review PMID 24009833
Motivation and drive
Animal
In five-hour operant-behaviour sessions, bromantane (20 mg/kg) increased the motivational component of rats' work — animals kept choosing to work longer. Human motivation claims do not exist in the verified record and are not made here.
Morozov 2000 · PMID 10934588
Mental performance, attention, operator activity
Review Human · small studies
The review of the Russian literature reports improved attention span and stability, complex sensorimotor reaction and operator-activity parameters in small human studies. Presented at review weight — suggestive, not definitive.
review PMID 24009833
Recovery after exertion
Review Animal
The review records that bromantane "was employed in the Soviet and Russian armies, to shorten recovery times after strong physical exertion, though not as widely as bemitil" — field use reported at review level, with no open primary field-trial report located.
review PMID 24009833
Immune support
Animal
Increased B-cell levels and circulating immune complexes after even a single dose; normalisation of T-cell subpopulations and the CD4/CD8 ratio in chronically stressed mice; lowered pro-inflammatory cytokines IL-6 and IL-17 in an anxiety-depression mouse model. No human immune-outcome trials exist — this area is animal-only and labelled so.
Tallerova et al. 2014 · PMID 24771370 · review PMID 24009833
§4 · Tolerability
The other side of the ledger
In the 728-patient trial, adverse effects occurred in 3% of patients and discontinuation in 0.8%, with no serious adverse events at 50–100 mg/day over 28 days. Russian prescribing information lists insomnia and hyperactivation as possible effects. Acute animal toxicity appears only at very high doses (motor stimulation at 30–300 mg/kg; toxic signs above 5 g/kg, attributed to anticholinergic actions irrelevant to clinical exposure). One honest caveat governs all of this: nearly every safety datum is Russian. No Western regulatory-grade safety database exists for bromantane, and this monograph does not pretend otherwise.
The citations behind every entry on this page are collected, with links, on Research & Sources; the pharmacology that explains them is on Mechanism of Action.
§5 · Citations
References for this page
- Voznesenskaia TG, Fokina NM, Iakhno NN. Treatment of asthenic disorders: multicenter study of ladasten (728 patients). Zh Nevrol Psikhiatr Korsakova. 2010;110(5 Pt 1):17-26. PMID 21322821
- Neznamov GG, Siuniakov SA, Teleshova SE, et al. Ladasten in neurasthenia: comparative clinical study with placebo. Zh Nevrol Psikhiatr Korsakova. 2009;109(5):20-6. PMID 19491814
- Morozov IS, Kleimenova NN. Effect of bromantane on physical work capacity. Eksp Klin Farmakol. 1998;61(6):51-3. PMID 9929819
- Oliynyk S, Oh S. The pharmacology of actoprotectors. Biomol Ther (Seoul). 2012;20(5):446-56. PMC3762282
- Tallerova AV, et al. Effect of bromantane on T-cell immunity in chronic stress. Bull Exp Biol Med. 2014;156(3):335-7. PMID 24771370