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Sponsors and Collaborators: |
Creighton University Shire Pharmaceutical Development |
Information provided by: | Creighton University |
ClinicalTrials.gov Identifier: | NCT00325286 |
This is an open label design using Lithium plus extended release carbamazepine (Equetro) in combination for 6 months. Rapid cycling bipolar disorder is frequently treatment refractory and associated with repeated hospitalizations and complications. The results of this study will offer a promising approach to treat this complex disorder. The primary efficacy measure will be the time to relapse. Relapse will determined by the investigator based on the following: Need for additional pharmacotherapy for mood-related symptoms, hospitalization for an mood episode, increase of more than 50% in HAM-D and YMRS scores from the baseline visit.
Condition | Intervention | Phase |
Bipolar Disorder |
Drug: Lithium Plus Extended- Release Carbamazepine |
Phase IV |
MedlinePlus related topics: | Bipolar Disorder |
ChemIDplus related topics: | Carbamazepine Lithium carbonate Lithium citrate |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open Label Prophylaxis Study of Lithium Plus Extended- Release Carbamazepine (Equetro®) Combination for Rapid Cycling Bipolar Disorder |
Estimated Enrollment: | 20 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | March 2008 |
Arms | Assigned Interventions |
1: Experimental
Treatment with lithium and extended release carbamazepine
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Drug: Lithium Plus Extended- Release Carbamazepine
Preliminary phase subjects receive ERC-CBZ starting dose range from 100 to 200 mg b.i.d. and further titration up to a maximum dose of 1600 mg/day done at the discretion of the investigator. Titration phase will not extend beyond 2 weeks.Open label phase subjects stabilized on lithium and ERC-CBZ therapy will enter this phase for 6 months
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Show Detailed Description |
Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Nebraska | |||||
Creighton University Department of Psychiatry | |||||
Omaha, Nebraska, United States, 68131 |
Creighton University |
Shire Pharmaceutical Development |
Principal Investigator: | Sriram Ramaswamy, M.D. | Creighton University |
Responsible Party: | Creighton University ( Sriram Ramaswamy, M.D., Assistant Professor of Psychiatry ) |
Study ID Numbers: | 05-13934 |
First Received: | May 10, 2006 |
Last Updated: | December 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00325286 |
Health Authority: | United States: Food and Drug Administration |
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