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Bro3.5
Bromantane (Ladasten) Research
Mostly mechanism / observationalLimited safety
6 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Bromantane (Ladasten) studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from mixed-quality studies published 1995–2010 with a typical study size of 728 participants.
Based on 6 studies · 728 total participants
Confidence
Low
By outcome
Anxiety & stress
Mostly mechanism / observational3 studies
Cognitive function
Mostly mechanism / observational3 studies
Asthenia, fatigue & work capacity
Too few graded studies2 studies
Safety profile
Too few graded studies2 studies
Immune support
Too few graded studies1 study
Older research base
Newest study from 2010
199520022010
1Open-Labeln=728 · large study2010
The percentage of responders was 76.0% on the CGI-S and 90.8% on the CGI-I. The antiasthenic effect of ladasten was seen on day 3 and remained during one month after the withdrawal of therapy.
Voznesenskaia TG, Fokina NM, Iakhno NN. · Zh Nevrol Psikhiatr Im S S Korsakova (2010)
Multicenter study across 28 Russian clinical centres; 728 patients with psychoautonomic syndrome and asthenic disorders analysed, treated with ladasten (bromantane) 50–100 mg/day for 28 days
High responder rates (76.0% CGI-S, 90.8% CGI-I); anti-asthenic effect appeared by day 3 and persisted one month after withdrawal
Reported efficacy for anxiety-depressive spectrum symptoms, autonomic dystonia and sleep disorders, with improved quality of life
2Animal1999
The main components of bromantan central neurotropic effect is its dopamine-positive activity: antagonism to the effects of neuroleptics in rats, blocking of dopamine synaptosomal capture, and a complicated influence on the serotoninergic mediator systems.
Morozov IS, Pukhova GS, Avdulov NA, Sergeeva SA, Spasov AA, Iezhitsa IN. · Eksp Klin Farmakol (1999)
Rat pharmacology study characterizing bromantane's central neurotropic mechanism
Showed a 'dopamine-positive' profile: antagonism of neuroleptic effects, blockade of synaptosomal dopamine reuptake, and modulation of serotonergic transmission (reuptake inhibition and altered 5-HT content)
Provides the proposed dopaminergic/serotonergic basis for the stimulant and anxiolytic effects
3Open-Label2006
Ladasten exhibits a unique combination of therapeutically significant stimulant and anxiolytic effects, which is unusual of psychostimulants.
Siuniakov SA, Grishin SA, Teleshova ES, Neznamov GG, Seredenin SB. · Eksp Klin Farmakol (2006)
Pilot (Phase-II) clinical trial of ladasten (bromantane) in patients with psychogenic asthenic disorder
Described an unusual combined profile of therapeutically significant psychostimulant and anxiolytic effects, with the psychostimulant action predominating on single administration
Concluded the stimulant-plus-anxiolytic combination is well suited to asthenic disorders
4Animal1995
Bromantane increased release and metabolism of dopamine in the dorsal striatum of freely moving rats.
Grekhova TV, Gaĭnetdinov RR, Sotnikova TD, Krasnykh LM, Kudrin VS, Sergeeva SA. · Biull Eksp Biol Med (1995)
In-vivo striatal microdialysis in freely-moving rats — a direct neurochemical measure of bromantane's dopaminergic action
Bromantane increased extracellular dopamine release and metabolism in the dorsal striatum
Frames bromantane as an immunostimulant with psychostimulant action acting via enhanced striatal dopamine
5Animal2001
Bromantan (N-[2-adamantil]-N-[para-bromphenyl]amine) is an actoprotective drug widely used in Russia... experiments were conducted to determine whether this compound has adverse effects on the reproduction and development of offspring.
Iezhitsa IN, Spasov AA, Bugaeva LI. · Neurotoxicol Teratol (2001)
Rat developmental-toxicity study in English (one of the few non-Russian-language bromantane papers) examining maternal oral dosing at 30, 150 and 600 mg/kg
Assessed effects of bromantane on offspring physical maturation and reflex development
Mixed, dose-non-monotonic effects on litter size and offspring reflexes (most marked at the LOWEST dose tested; many differences non-significant) — uncertain but enough to support the pregnancy "avoid" rating
Bromantane (bromantan) acts as both a stimulant and a masking agent, prompting its inclusion among prohibited doping substances after positive tests at the 1996 Atlanta Olympics.
Burnat P, Payen A, Le Brumant-Payen C, Hugon M, Ceppa F. · Lancet (1997)
Lancet correspondence (an independent, non-Russian source) describing bromantane as a newly recognized doping agent
Bromantane came to attention after Russian athletes tested positive at the 1996 Atlanta Olympics; it acts as both a stimulant and a masking agent
Documents the basis for bromantane's WADA prohibition — key counter-context to any 'performance' use