A peptide brain therapy (Cerebrolysin) significantly reduced anxiety after traumatic brain injury with a large effect size of 0.73 compared to placebo.
0.73 effect size on anxietyCerebrolysin produced a large effect size (0.73) for anxiety reduction — considered clinically meaningful — in moderate-to-severe TBI patients
What the researchers found
Cerebrolysin, a peptide preparation derived from pig brain tissue, significantly reduced anxiety in patients with moderate and severe traumatic brain injury (TBI) compared to placebo. Statistically significant differences in HADS-Anxiety scores were found at both the second and third follow-up visits, with a large effect size of 0.73.
The study also identified correlations between anxiety/depression scores and other neuropsychological measures, suggesting that post-TBI mental health is connected to cognitive and motor recovery. The patient sample had a mean age of 45.3, was primarily male, and had a 24-hour Glasgow Coma Scale mean of 12.67 (indicating moderate-to-severe injury).
Why it matters
Traumatic brain injury frequently causes depression, anxiety, and cognitive impairment that persist long after the initial injury. There are few treatments specifically designed for post-TBI psychiatric symptoms. The finding that Cerebrolysin — already used in some countries for neurological recovery — could significantly reduce post-TBI anxiety with a large effect size suggests it may address both the neurological and psychiatric consequences of brain injury.
The numbers in context
n=125 · Effect size 0.73 (large) for anxiety · Mean age 45.3 · GCS mean 12.67 · Significant at visits 2 and 3 · HADS-Anxiety/Depression assessed
How the study worked
This was a secondary retrospective analysis of the CAPTAIN II trial data. 125 TBI patients with moderate and severe disability were divided into two groups: Cerebrolysin treatment and saline placebo. Researchers used the Hospital Anxiety and Depression Scale (HADS) to measure psychiatric outcomes, Spearman's correlations to assess relationships between HADS and other neuropsychological scales, and Mann-Whitney U tests to compare anxiety and depression scores between treatment groups.
Who was studied
125 patients with moderate and severe traumatic brain injury, primarily male, mean age 45.3, mean 24-hour GCS of 12.67
What this study cannot tell us
This is a retrospective secondary analysis, not a prospectively designed psychiatric outcomes trial. The sample of 125 patients is moderate in size. The analysis was conducted post-hoc on an existing database, increasing the risk of finding spurious associations. The authors explicitly note that confirmatory trials are needed. Cerebrolysin is not FDA-approved and its mechanisms remain debated.
How to read the evidence
This is a moderate-grade study: a secondary retrospective analysis of a placebo-controlled trial. While the original CAPTAIN II trial was well-designed, this specific analysis was post-hoc and the authors explicitly call for confirmatory trials.
When this study was published
Published in 2022, this is a recent analysis that adds to the growing evidence base for Cerebrolysin in TBI. The parent CAPTAIN II trial data provides a robust foundation, though the psychiatric outcomes were not the primary study endpoint.
The bigger picture
Cerebrolysin is one of the few neurotrophic peptide preparations that has reached clinical use (approved in over 40 countries, though not in the US). This analysis adds psychiatric outcomes to its evidence base, which has primarily focused on cognitive recovery. The connection between anxiety, depression, and cognitive function after TBI reinforces the idea that effective neurological recovery requires addressing mental health simultaneously — and that neuropeptide therapies may help on both fronts.
Questions still open
- Would a prospectively designed trial specifically targeting post-TBI anxiety confirm these findings?
- Does Cerebrolysin's effect on anxiety persist long-term, or does it diminish after treatment ends?
- Could Cerebrolysin benefit patients with mild TBI who also develop anxiety and cognitive symptoms?
Common questions
What is Cerebrolysin and how might it help after brain injury?
Why do brain injuries cause anxiety and depression?
Read the original research
The Effect of Cerebrolysin on Anxiety, Depression, and Cognition in Moderate and Severe Traumatic Brain Injury Patients: A CAPTAIN II Retrospective Trial Analysis.
Medicina (Kaunas, Lithuania), 58(5)
Citation
Mureșanu, Ioana Anamaria; Grad, Diana Alecsandra; Mureșanu, Dafin Fior; Hapca, Elian; Benedek, Irina; Jemna, Nicoleta; Strilciuc, Ștefan; Popescu, Bogdan Ovidiu; Perju-Dumbravă, Lăcrămioara; Cherecheș, Răzvan Mircea. (2022). The Effect of Cerebrolysin on Anxiety, Depression, and Cognition in Moderate and Severe Traumatic Brain Injury Patients: A CAPTAIN II Retrospective Trial Analysis.. Medicina (Kaunas, Lithuania), 58(5). https://doi.org/10.3390/medicina58050648