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Bro3.5

Bromantane (Ladasten) Research

Mostly mechanism / observational

10 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 medium-quality randomised trials published 1995–2012 with a typical study size of 728 participants.

Based on 10 studies · 4 RCTs · 728 total participants

Confidence

Moderate confidence

By outcome

Asthenia, fatigue & work capacityUsed for asthenia (pathological fatigue); a 728-patient Russian multicenter study reported high response rates with stimulant-like alertness · Days to weeks of dosing
Mostly mechanism / observational4 studies
Anxiety & stressShows an anxiolytic effect in stress-reactive rodents, and the multicenter human study reported improvement in anxiety alongside the anti-fatigue effect · Days to weeks of dosing
Mostly mechanism / observational4 studies
Cognitive function
Mostly mechanism / observational4 studies
Safety profile
Too few graded studies2 studies
Immune support
Too few graded studies1 study

Older research base

Newest study from 2012

199520032012

1RCT2011

Reutova MA, Siuniakov SA, Siuniakov TS, Dorofeeva OA, Mametova LÉ, Neznamov GG · Eksp Klin Farmakol (2011)

2RCT2009

Neznamov GG, Siuniakov SA, Teleshova SE, Chumakov DV, Reutova MA, Siuniakov TS · Zh Nevrol Psikhiatr Im S S Korsakova (2009)

3RCT2012

Neznamov GG, Bochkarev VK, Reutova MA, Shabanova AA, Siuniakov SA · Eksp Klin Farmakol (2012)

4RCT2011

Sarycheva TN, Rybak VA, Kurushina OV · Zh Nevrol Psikhiatr Im S S Korsakova (2011)

5Animal1999

In plain English: 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

6Open-Labeln=728 · large study2010

In plain English: 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

7Animal2001

In plain English: 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

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8Open-Label2006

In plain English: 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

9Animal1995

In plain English: 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

10Case Study1997

In plain English: 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

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View in Research Library

Bromantane (Ladasten) Research

Mostly mechanism / observational

[Self-evaluation of single test doses and objective indices of ladasten vs. placebo efficacy in neurasthenic patients].

[Ladasten, the new drug with psychostimulant and anxiolytic actions in treatment of neurasthenia (results of the comparative clinical study with placebo)].

[Ladasten versus placebo effect self-evaluated by neurasthenia patients with different EEG alpha rhythm types].

[Ladasten in the management of non-motor symptoms of Parkinson's disease].

[The mechanisms of the neurotropic action of bromantan].

[Treatment of asthenic disorders in patients with psychoautonomic syndrome: results of a multicenter study on efficacy and safety of ladasten].

Effects of bromantan on offspring maturation and development of reflexes.

[Pilot clinical trial of ladasten].

[The effect of bromantane, a new immunostimulant with psychostimulating action, on release and metabolism of dopamine in the dorsal striatum of freely moving rats: a microdialysis study].

Bromontan, a new doping agent.