TY - JOUR
T1 - Beneficial effect of digoxin-specific Fab fragments in bipolar disorder- a preliminary study
AU - Zilberstein, Ariel
AU - Krivoy, Norberto
AU - Horesh, Noa
AU - Klein, Ehud
AU - Lichtstein, David
N1 - Publisher Copyright:
© 2023
PY - 2023/7
Y1 - 2023/7
N2 - Background: A vast amount of experimental data supports the notion that Na+, K+-ATPase and endogenous cardiac steroids (ECS) such as digoxin and ouabain are involved in bipolar disorders. The aim of the study was to examine the possible beneficial effect of Digoxin-specific antibody Fab fragments Digibind, in bipolar disorder (BD) patients. Methods: In a pilot, open-label study without a control group, BD inpatient subjects received a single dose of Digibind, injected intravenously. During the 72 hrs following the intervention. the response to Digibind was measured using the Montgomery-Asberg Depression Rating Scale (MADRS). Results: A total 6 patients with a moderate to severe bipolar depressive episode (MADRS 30.3, 24–38) participated in the study. We found a significant clinical improvement at all time points after Digibind administration, manifested by a maximal decrease in the MADRS score of 8.3 points at 24 hrs, followed by a gradual rebound to baseline scores. Limitations: No control group was included, treatment was open-label, and only 6 patients were studied. Conclusions: This preliminary study showed that a one-time injection of Digibind resulted in a transient significant beneficial effect on depression symptoms in BD patients.
AB - Background: A vast amount of experimental data supports the notion that Na+, K+-ATPase and endogenous cardiac steroids (ECS) such as digoxin and ouabain are involved in bipolar disorders. The aim of the study was to examine the possible beneficial effect of Digoxin-specific antibody Fab fragments Digibind, in bipolar disorder (BD) patients. Methods: In a pilot, open-label study without a control group, BD inpatient subjects received a single dose of Digibind, injected intravenously. During the 72 hrs following the intervention. the response to Digibind was measured using the Montgomery-Asberg Depression Rating Scale (MADRS). Results: A total 6 patients with a moderate to severe bipolar depressive episode (MADRS 30.3, 24–38) participated in the study. We found a significant clinical improvement at all time points after Digibind administration, manifested by a maximal decrease in the MADRS score of 8.3 points at 24 hrs, followed by a gradual rebound to baseline scores. Limitations: No control group was included, treatment was open-label, and only 6 patients were studied. Conclusions: This preliminary study showed that a one-time injection of Digibind resulted in a transient significant beneficial effect on depression symptoms in BD patients.
KW - Bipolar disorder
KW - Cardiac steroids, Digoxin
KW - Depression
KW - Digibind
KW - Na,K-ATPase
UR - http://www.scopus.com/inward/record.url?scp=85160332890&partnerID=8YFLogxK
U2 - 10.1016/j.jadr.2023.100600
DO - 10.1016/j.jadr.2023.100600
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AN - SCOPUS:85160332890
SN - 0941-9500
VL - 13
JO - Journal of Affective Disorders Reports
JF - Journal of Affective Disorders Reports
M1 - 100600
ER -