Antibodies to Digoxin for Bipolar Disorder

Rambam Health Care Campus

Status and phase: Completed; Phase 2

Conditions: Bipolar Disorder

Treatments: Drug: Digibind (Fab)

Study type: Interventional

Funder types: Other

Identifiers

NCT00550576

IRB2142_CTIL

Details and patient eligibility

About

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

Full 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

Enrollment: 18 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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18 participants in 1 patient group

digibind

Experimental group

Description:

Injection of digibind and psychological tests

Treatment:

Drug: Digibind (Fab)