Clinical effects of central antagonist of cholecystokinin-1 receptors GB-115 in patients with Generalized Anxiety Disorder

Dorofeeva O, Syunyakov T, Metlina M, Ivashkina N

European psychiatry : the journal of the Association of European Psychiatrists1 Sept 2022

PMCIDPMC9564032PepBankPUB-91970474

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Summary

Introduction The pilot clinical study of GB-115, a new peptide antagonist of central cholecystokinin-1 receptors, revealed that drug was clinically effective in patients with generalized anxiety disorder (GAD) at dose 6 mg daily. Here, we provide results of post-hoc analysis of changes of anxiety and fatigue symptoms to give characterization of its clinical effects in clinically relevant doses. Objectives To research the changes of anxiety- and fatigue-related symptoms during GB-115 treatment in patients with generalized anxiety disorder (GAD). Methods Patients with GAD without somatic diseases aged 18-55 years were eligible in the study. Patients were prescribed with GB-115 6 mg daily for 21 days. Anxiety and fatigue symptoms were assessed with Hamilton Anxiety Rating Scale (HARS) and Multidimensional Fatigue Inventory (MFI-20). Variables are described as medians and interquartile range (IQR). Pre-post comparisons were performed using the Friedman ANOVA at 2-side p-value <0.05. Results 25 patients diagnosed with GAD (8 males, 17 females; median [IQR] age: 34 [29.75, 43.0]) included in the analysis. Median [IQR] HARS total score decreased from 22 [20, 24.5] to 19 [16, 20], 13 [10.5, 15.5], 9 [5.5, 11] and 5 [3.5, 8] on the Day 3,7,14 and 21, respectively (χ2=95.07, df=4, p<0.001). Median [IQR] MFI-20 score decreased from 70 [46, 75.5] to 59 [41, 74.5], 52 [37.5, 64.5], 37 [26.5, 63] and 28 [24, 48.5] on the Day 3, 7, 14 and 21, respectively (χ2= 55.41, df=4, p<0.001). None of patients had stimulation-related side effects. Conclusions GB-115 action in the treatment of GAD patients is characterized with anxiolytic action with mild psychostimulant properties. Disclosure No significant relationships.

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.

01HumanNon-randomized trialEfficacy outcome
In patients with generalized anxiety disorder, HARS scores decreased from baseline during GB‑115 treatment.
In plain wordsIn patients with generalized anxiety disorder, anxiety scores decreased from baseline during GB‑115 treatment.
Peptide
GB-115
Outcome
DecreaseHARS total score
Study
n = 25
Comparator
Baseline
Outcome group
Anxiety and mood · Mental health and mood
Studied dose
6 mg daily · 21 daysAs given in this study (human).
Measurements
Median HARS score
22 score
baseline
Median HARS score
19 score
Day 3
Median HARS score
13 score
Day 7
Median HARS score
9 score
Day 14
Median HARS score
5 score
Day 21
Source sentences
Summary
Median [IQR] HARS total score decreased from 22 [20, 24.5] to 19 [16, 20], 13 [10.5, 15.5], 9 [5.5, 11] and 5 [3.5, 8] on the Day 3,7,14 and 21, respectively (χ2=95.07, df=4, p<0.001).
3 context sentences(design, population, supporting numbers)
Summary · context
Patients with GAD without somatic diseases aged 18-55 years were eligible in the study.
Summary · context
Patients were prescribed with GB-115 6 mg daily for 21 days.
Summary · context
25 patients diagnosed with GAD (8 males, 17 females; median [IQR] age: 34 [29.75, 43.0]) included in the analysis.
Show in the study text Report a problemFND-9197047401
02HumanNon-randomized trialEfficacy outcome
In patients with generalized anxiety disorder, MFI-20 fatigue scores decreased from baseline during GB‑115 treatment.
In plain wordsIn patients with generalized anxiety disorder, fatigue scores decreased from baseline during GB‑115 treatment.
Peptide
GB-115
Outcome
DecreaseMFI-20 score
Study
n = 25
Comparator
Baseline
Outcome group
Exercise and physical function · Whole body
Studied dose
6 mg daily · 21 daysAs given in this study (human).
Measurements
Median MFI-20 score
70 score
baseline
Median MFI-20 score
59 score
Day 3
Median MFI-20 score
52 score
Day 7
Median MFI-20 score
37 score
Day 14
Median MFI-20 score
28 score
Day 21
Source sentences
Summary
Median [IQR] MFI-20 score decreased from 70 [46, 75.5] to 59 [41, 74.5], 52 [37.5, 64.5], 37 [26.5, 63] and 28 [24, 48.5] on the Day 3, 7, 14 and 21, respectively (χ2= 55.41, df=4, p<0.001).
3 context sentences(design, population, supporting numbers)
Summary · context
Patients with GAD without somatic diseases aged 18-55 years were eligible in the study.
Summary · context
Patients were prescribed with GB-115 6 mg daily for 21 days.
Summary · context
25 patients diagnosed with GAD (8 males, 17 females; median [IQR] age: 34 [29.75, 43.0]) included in the analysis.
Show in the study text Report a problemFND-9197047402
03HumanNon-randomized trialSafety outcome
In patients with generalized anxiety disorder, none had stimulation-related side effects during GB‑115 treatment.
In plain wordsIn patients with generalized anxiety disorder, none had stimulation-related side effects during GB‑115 treatment.
Peptide
GB-115
Outcome
Not applicableStimulation-related side effects
Study
n = 25
Outcome group
Adverse events · Whole body
Studied dose
6 mg daily · 21 daysAs given in this study (human).
Source sentences
Summary
None of patients had stimulation-related side effects.
3 context sentences(design, population, supporting numbers)
Summary · context
Patients with GAD without somatic diseases aged 18-55 years were eligible in the study.
Summary · context
Patients were prescribed with GB-115 6 mg daily for 21 days.
Summary · context
25 patients diagnosed with GAD (8 males, 17 females; median [IQR] age: 34 [29.75, 43.0]) included in the analysis.
Show in the study text Report a problemFND-9197047403

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Version 2Current
27 Oct 2026, 18:20 UTC
Study results updated
Version 1
27 Oct 2026, 16:32 UTC
First added · source update from Europe PMC

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