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Antibodies to Digoxin for Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Digibind (Fab)
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Digoxin Antibodies, Bipolar Disorder

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rambam Health Care Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

digibind

Arm Description

Injection of digibind and psychological tests

Outcomes

Primary Outcome Measures

improvement

Secondary Outcome Measures

Full Information

First Posted
October 29, 2007
Last Updated
June 10, 2013
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT00550576
Brief Title
Antibodies to Digoxin for Bipolar Disorder
Official Title
Antibodies to Digoxin for Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Digoxin Antibodies, Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
digibind
Arm Type
Experimental
Arm Description
Injection of digibind and psychological tests
Intervention Type
Drug
Intervention Name(s)
Digibind (Fab)
Intervention Description
Intravenous Digibind (Digoxin Antibodies-Fab) is delivered only once in 30-45 minutes to patients after receiving the informed concent.
Primary Outcome Measure Information:
Title
improvement
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehaud Klein, Professor
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Study Director
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel

12. IPD Sharing Statement

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Antibodies to Digoxin for Bipolar Disorder

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