|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Tuscaloosa Research & Education Advancement Corporation |
|---|---|
| Collaborator: |
Shire Pharmaceutical Development |
| Information provided by: | Tuscaloosa Research & Education Advancement Corporation |
| ClinicalTrials.gov Identifier: | NCT00203567 |
Purpose
To study the efficacy and safety of beaded extended-release Carbamazepine (Equetro) in the treatment of patients with Bipolar Disorder with a Major Depressive Episode.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Depression |
Drug: carbamazepine ER |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Carbamazepine Extended-Release for the Treatment of Bipolar Depression |
| Enrollment: | 25 |
| Study Start Date: | August 2005 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Equetro
Equetro
|
Drug: carbamazepine ER
Active study drug, no comparator
|
Patients with Bipolar I or II Disorder with a Major Depressive Episode who sign informed consent and meet eligibility criteria will begin treatment with extended release carbamazepine (ERC-CBZ ). The dose of ERC-CBZ will be initiated at 200mg twice daily and increased as tolerated by 200mg/day every 3 days up to 1200mg/day by week 2 (target dose). Then the dose may be increased at the investigator's discretion, up to1600mg/day as tolerated by week 8, if needed for a greater therapeutic response. Efficacy will be assessed biweekly with the Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impression-Bipolar (CGI-BP). Safety is assessed biweekly with adverse events self-reports and laboratory evaluations. ).
Eligibility| Ages Eligible for Study: | 19 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Clinically significant abnormal laboratory tests results:
Contacts and Locations| United States, Alabama | |
| Tuscaloosa Research and Education Advancement Corporation | |
| Tuscaloosa, Alabama, United States, 35404 | |
| Principal Investigator: | Lori L Davis, MD | Tuscaloosa VA Medical Center |
More Information
| Responsible Party: | Lori L. Davis, M.D.; Chief, Research Service, Tuscaloosa Research Education & Advancement Corporation |
| ClinicalTrials.gov Identifier: | NCT00203567 History of Changes |
| Other Study ID Numbers: | TREAC Equetro in Bipolar, TREAC Equetro in Bipolar |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 23, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
bipolar depression carbamazepine ER Equetro |
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms Carbamazepine Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |