Antibodies to Digoxin for Bipolar Disorder

Phase 2

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Digibind (Fab)

• Registration Number: NCT00550576
• Lead Sponsor: Rambam Health Care Campus

Brief 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

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-29
• Study First Submitted QC: 2007-10-29
• Study First Posted: 2007-10-30
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-10
• Last Update Posted: 2013-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Admitted patients suffering from Bipolar Disorder
• abillity to give informed concent

Exclusion Criteria

• Allergy to Digoxin Antibodies
• Renal and Liver function impairment
• Liver Cirrhosis
• Asthma
• Patients on Digoxin or Digitoxin
• Patients receiving Aldactone therapy
• Heart A-V Block
• Hypo or Hyperkalemia on admission
• Potential Suicidal Behaviour

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
digibind	Digibind (Fab)	Injection of digibind and psychological tests

Primary Outcome Measures

Name	Time	Method
improvement	24 hours

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel