NCT00550576

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

1.3 years

First QC Date

October 29, 2007

Last Update Submit

June 10, 2013

Conditions

Bipolar Disorder

Keywords

Digoxin AntibodiesBipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • improvement

    24 hours

Study Arms (1)

digibind

EXPERIMENTAL

Injection of digibind and psychological tests

Drug: Digibind (Fab)

Interventions

Digibind (Fab)DRUG

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

digibind

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted patients suffering from Bipolar Disorder
  • abillity to give informed concent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

digoxin antibodies Fab fragmentsImmunoglobulin Fab Fragments

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Immunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • Ehaud Klein, Professor

    Rambam Health Care Campus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2007

First Posted

October 30, 2007

Study Start

October 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations

IL(1)