Antibodies to Digoxin for Bipolar Disorder

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00550576

Enrollment

Registered

2007-10-30

Start date

2007-10-31

Completion date

2009-02-28

Last updated

2013-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Digoxin Antibodies, Bipolar Disorder

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

Interventions

DRUGDigibind (Fab)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
improvement	24 hours

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026