Official Title: “Antibodies to Digoxin for Bipolar Disorder”

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

Study Type: Interventional

Study Design: Treatment, Single Blind (Subject), Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: digibind
  • Injection of digibind and psychological tests

Primary Measures

• improvement
  • Time Frame: 24 hours
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Rambam Health Care Campus

Overall Clinical Trial Officials and Contacts

Ehaud Klein, Professor Study Director Rambam Health Care Campus  

Overall Contact: Ehud Klein, Professor (972)48542958 e_klein@rambam.health.gov.il

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00550576

Study ID Number: IRB2142_CTIL

ClinicalTrials.gov Identifier: NCT00550576

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration