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| Sponsor: | Rambam Health Care Campus |
|---|---|
| Information provided by: | Rambam Health Care Campus |
| ClinicalTrials.gov Identifier: | NCT00550576 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: Digibind (Fab) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Antibodies to Digoxin for Bipolar Disorder |
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2007 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Rambam Health Care Campus |
| ClinicalTrials.gov Identifier: | NCT00550576 History of Changes |
| Other Study ID Numbers: | IRB2142_CTIL |
| Study First Received: | October 29, 2007 |
| Last Updated: | February 15, 2009 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
|
Digoxin Antibodies Bipolar Disorder |
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Antibodies Immunoglobulins Digoxin Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Protective Agents |
