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| Sponsor: | Creighton University |
|---|---|
| Collaborator: |
Shire Pharmaceutical Development |
| Information provided by: | Creighton University |
| ClinicalTrials.gov Identifier: | NCT00325286 |
Purpose
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 |
| 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
|
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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Hide Detailed DescriptionOpen label Design with Lithium plus Extended release carbamazepine combination for 6 months. Extended release carbamazepine at doses of 1600 mg/day will be utilized. Lithium dosage will be adjusted to maintain therapeutic blood levels.
Patient Population: N = 20.
Primary and Secondary Efficacy Endpoints:
The primary efficacy measure will be the time to relapse. Relapse will determined by the investigator based on the following
The differences in the frequency of affective episodes in the 6-month prior to the treatment with ERC-CBZ and 6 months after treatment initiation will also be measured. Secondary efficacy measures will include; changes in the 17- Item Hamilton Depression Scale (HAM-D), Young Mania Rating Scale (YMRS), Clinical Global Severity Scale (CGI -S), Clinical Global Improvement Scale (CGI-I) scores at baseline and scores during treatment with ERC-CBZ.
Inclusion Criteria:
Exclusion Criteria:
Study Procedures:
Preliminary Phase: The Structured Clinical Interview Diagnostic Schedule (SCID), medical & psychiatric history and baseline laboratory testing, EKG; pregnancy test will be obtained to ensure study eligibility. Eligible subjects will receive ERC-CBZ at starting doses ranging from 100 to 200 mg b.i.d. depending on clinical presentation and further titration up to a maximum dose of 1600 mg/day will be done at the discretion of the investigator. This titration phase will not extend beyond 2 weeks during which changes in concomitant medications will be allowed. Next, all psychotropics excluding lithium, ERC-CBZ and benzodiazepines will be tapered over a 2-week period. During the preliminary phase subjects will be seen weekly and assessments will be made using the HAM-D, YMRS, CGI -S, CGI-I, AE, and Concomitant medications
Open Label Phase: Subjects on lithium and ERC-CBZ therapy will enter this phase for 6 months. Changes to both lithium and ERC-CBZ will be permitted during this phase with serum levels to guide titration. Use of lorazepam, as a rescue medication will be permitted. Study visits will be every biweekly for 6 months. The HAM-D, YMRS and CGI-S, CGI-I, AE, concomitant medications will be assessed at each visit. Compliance will be assessed by pill counts at each study visit.
Eligibility| Ages Eligible for Study: | 19 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Nebraska | |
| Creighton University Department of Psychiatry | |
| Omaha, Nebraska, United States, 68131 | |
| Principal Investigator: | Sriram Ramaswamy, M.D. | Creighton University |
More Information
| Responsible Party: | Creighton University ( Sriram Ramaswamy, M.D., Assistant Professor of Psychiatry ) |
| Study ID Numbers: | 05-13934 |
| Study First Received: | May 10, 2006 |
| Last Updated: | December 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00325286 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Affective Disorders, Psychotic Pathologic Processes Sensory System Agents Mental Disorders Therapeutic Uses Analgesics Lithium Antidepressive Agents Disease Tranquilizing Agents |
Bipolar Disorder Lithium Carbonate Central Nervous System Depressants Enzyme Inhibitors Antimanic Agents Antipsychotic Agents Pharmacologic Actions Carbamazepine Analgesics, Non-Narcotic Mood Disorders Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |