NCT00550576

Antibodies to Digoxin for Bipolar Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Subjects suffering from bipolar disorders treated with specific medications will give their informed concent and will receive intravenously only one dose of Digoxin antibodies (Fab). Their response to this therapy will be measured accordingly.Previous medications will be not changed A base line serum Endogenous Digitalis-like Compounds (DLC)levels will be measured using a specific laboratory technique and these compounds will be measured at 6 and 24 hours after Fab therapy. Patients also will be followed using clinical and psychological tests

Detailed description

Twenty subjects suffering from bipolar disorders treated with specific medications will give their informed concent and will included in the study. All will receive in an open study only one intravenously dose of Digoxin antibodies (Fab). Their response to this therapy will be measured accordingly.Previous medications will be not changed A base line serum Endogenous Digitalis-like Compounds (DLC)levels will be measured using a specific laboratory technique and these compounds will be measured at 6 and 24 hours after Fab therapy. Patients also will be followed using clinical and psychological tests

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Digibind (Fab)	Intravenous Digibind (Digoxin Antibodies-Fab) is delivered only once in 30-45 minutes to patients after receiving the informed concent.

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2007-10-30
• Last updated: 2013-06-11

Locations

1 site across 1 country: Israel