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| Sponsored by: |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Single Blind (Subject), Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Antibodies to Digoxin for Bipolar Disorder |
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | November 2009 |
| Arms | Assigned Interventions |
|---|---|
|
digibind: Experimental
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| Contact: Ehud Klein, Professor | (972)48542958 | e_klein@rambam.health.gov.il |
| Contact: Sara Marmor, Dr. | s_marmor@rambam.health.gov.il |
| Israel | |
| Rambam Health Care Campus | Recruiting |
| Haifa, Israel | |
| Contact: Ariel Silbershtein, Dr. | |
| Contact: Norberto Krivoy, Professor (972)502063185 n_krivoy@rambam.health.gov.il | |
| Principal Investigator: Ariel Silbershtein, Dr. | |
| Study Director: | Ehaud Klein, Professor | Rambam Health Care Campus |
More Information
| Responsible Party: | Rambam Health Care Campus ( Rambam Health Care Campus ) |
| Study ID Numbers: | IRB2142_CTIL |
| Study First Received: | October 29, 2007 |
| Last Updated: | December 9, 2007 |
| ClinicalTrials.gov Identifier: | NCT00550576 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
|
Digoxin Antibodies Bipolar Disorder |
|
Antibodies Affective Disorders, Psychotic Mental Disorders Bipolar Disorder |
Mood Disorders Digoxin Psychotic Disorders Immunoglobulins |
|
Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Immunologic Factors Cardiotonic Agents Therapeutic Uses |
Physiological Effects of Drugs Enzyme Inhibitors Anti-Arrhythmia Agents Cardiovascular Agents Protective Agents Pharmacologic Actions |
