Antibodies to Digoxin for Bipolar Disorder
Information source: Rambam Health Care Campus
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Digibind (Fab) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Rambam Health Care Campus Official(s) and/or principal investigator(s):
Ehaud Klein, Professor, Study Director, Affiliation: Rambam Health Care Campus
Overall contact:
Ehud Klein, Professor, Phone: (972)48542958, Email: e_klein@rambam.health.gov.il
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
Clinical Details
Official title: Antibodies to Digoxin for Bipolar Disorder
Study design: Treatment, Single Blind (Subject), Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: improvement
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
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Ehud Klein, Professor, Phone: (972)48542958, Email: e_klein@rambam.health.gov.il
Rambam Health Care Campus, Haifa, Israel; Recruiting
Ariel Silbershtein, Dr.
Norberto Krivoy, Professor, Phone: (972)502063185, Email: n_krivoy@rambam.health.gov.il
Ariel Silbershtein, Dr., Principal Investigator
Additional Information
Starting date: October 2007
Ending date: November 2009
Last updated: December 9, 2007
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