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Trial record 6 of 13 for:    digitalis

Antibodies to Digoxin for Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00550576
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : June 11, 2013
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Digibind (Fab) Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Antibodies to Digoxin for Bipolar Disorder
Study Start Date : October 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: digibind
Injection of digibind and psychological tests
Drug: Digibind (Fab)
Intravenous Digibind (Digoxin Antibodies-Fab) is delivered only once in 30-45 minutes to patients after receiving the informed concent.




Primary Outcome Measures :
  1. improvement [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550576


Locations
Israel
Rambam Health Care Campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Study Director: Ehaud Klein, Professor Rambam Health Care Campus

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00550576     History of Changes
Other Study ID Numbers: IRB2142_CTIL
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: June 11, 2013
Last Verified: June 2013

Keywords provided by Rambam Health Care Campus:
Digoxin Antibodies
Bipolar Disorder

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Antibodies
Immunoglobulins
Digoxin
Immunologic Factors
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents