The Effect of Cerebrolysin on Anxiety, Depression, and Cognition in Moderate and Severe Traumatic Brain Injury Patients: A CAPTAIN II Retrospective Trial Analysis.

Mureșanu IA, Grad DA, Mureșanu DF, Hapca E, Benedek I, Jemna N, Strilciuc Ș, Popescu BO, Perju-Dumbravă L, Cherecheș RM

Medicina (Kaunas, Lithuania)9 May 2022Cited by 8 (Europe PMC)

PMID35630065PMCIDPMC9147297DOI10.3390/medicina58050648PepBankPUB-35630065

Summary

Background and Objectives: Traumatic brain injuries represent an important source of disease burden requiring emergency inpatient care and continuous outpatient tailored rehabilitation. Although most TBIs are mild, patients are still developing post-TBI depression, anxiety, and cognitive impairments. Our secondary retrospective trial analysis aimed to (1) analyze correlations between HADS-Anxiety/HADS-Depression and scales that measure cognitive and motor processes in patients treated with Cerebrolysin compared to the placebo group and (2) compare anxiety and depression scores among the two treatment groups. Materials and Methods: Our secondary retrospective analysis focused on TBI patients with moderate and severe disability divided into two groups: Cerebrolysin (treatment) and saline solution (procedural placebo). We analyzed data from 125 patients. We computed descriptive statistics for nominal and continuous variables. We used Spearman's correlation to find associations between HADS and other neuropsychological scales and the Mann-Whitney U test to compare HADS-Anxiety and HADS-Depression scores among the two study arms. Results: Our sample consisted of patients with a mean age of 45.3, primarily men, and with a 24 h GCS (Glasgow Coma Scale) mean of 12.67. We obtained statistically significant differences for HADS-Anxiety during the second and third visits for patients treated with Cerebrolysin. Our results show that Cerebrolysin has a large effect size (0.73) on anxiety levels. In addition, there are positive and negative correlations between HADS-Anxiety and Depression subscales and other neuropsychological scales. Conclusions: Our secondary database analysis supports the existing body of evidence on the positive effect of Cerebrolysin on post-TBI mental health status. Future confirmatory trials are necessary to clarify the link between the intervention and measured outcomes.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

01HumanObservational studyEfficacy outcome
In moderate and severe TBI patients, HADS-Anxiety differed significantly between Cerebrolysin and placebo at the second visit.
In plain wordsIn TBI patients, anxiety scores differed significantly between Cerebrolysin and placebo at the second visit.
Peptide
Cerebrolysin
Outcome
Direction not reportedHADS-Anxiety second visit
Study
n = 125
Comparator
Saline placebo
Outcome group
Anxiety and mood · Mental health and mood
Studied dose
Dose not stated
Source sentences
Summary
We obtained statistically significant differences for HADS-Anxiety during the second and third visits for patients treated with Cerebrolysin.
2 context sentences(design, population, supporting numbers)
Summary · context
Our secondary retrospective analysis focused on TBI patients with moderate and severe disability divided into two groups: Cerebrolysin (treatment) and saline solution (procedural placebo).
Summary · context
We analyzed data from 125 patients.
Show in the study text Report a problemFND-3563006501
02HumanObservational studyEfficacy outcome
In moderate and severe TBI patients, HADS-Anxiety differed significantly between Cerebrolysin and placebo at the third visit.
In plain wordsIn TBI patients, anxiety scores differed significantly between Cerebrolysin and placebo at the third visit.
Peptide
Cerebrolysin
Outcome
Direction not reportedHADS-Anxiety third visit
Study
n = 125
Comparator
Saline placebo
Outcome group
Anxiety and mood · Mental health and mood
Studied dose
Dose not stated
Source sentences
Summary
We obtained statistically significant differences for HADS-Anxiety during the second and third visits for patients treated with Cerebrolysin.
2 context sentences(design, population, supporting numbers)
Summary · context
Our secondary retrospective analysis focused on TBI patients with moderate and severe disability divided into two groups: Cerebrolysin (treatment) and saline solution (procedural placebo).
Summary · context
We analyzed data from 125 patients.
Show in the study text Report a problemFND-3563006502
03HumanObservational studyEfficacy outcome
In TBI patients, Cerebrolysin had an anxiety effect size of 0.73 compared with placebo.
In plain wordsIn TBI patients, Cerebrolysin had an anxiety effect size of 0.73 compared with placebo.
Peptide
Cerebrolysin
Outcome
Direction not reportedAnxiety effect size
Study
n = 125
Comparator
Saline placebo
Outcome group
Anxiety and mood · Mental health and mood
Studied dose
Dose not stated
Measurements
Effect size
0.73
Anxiety
Source sentences
Summary
Our results show that Cerebrolysin has a large effect size (0.73) on anxiety levels.
2 context sentences(design, population, supporting numbers)
Summary · context
Our secondary retrospective analysis focused on TBI patients with moderate and severe disability divided into two groups: Cerebrolysin (treatment) and saline solution (procedural placebo).
Summary · context
We analyzed data from 125 patients.
Show in the study text Report a problemFND-3563006503

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Version history

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Version 2Current
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

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