Antibodies to Digoxin for Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Antibodies to Digoxin for Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00550576
• Other study ID #: IRB2142_CTIL
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2007
• Last updated: June 10, 2013
• Start date: October 2007
• Est. completion date: February 2009

Study information

• Verified date: June 2013
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Digibind (Fab)
Intravenous Digibind (Digoxin Antibodies-Fab) is delivered only once in 30-45 minutes to patients after receiving the informed concent.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement		24 hours	No