CLINICAL TRIALS PROFILE FOR EQUETRO
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All Clinical Trials for EQUETRO
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00181870 ↗ | Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder | Completed | Shire | Phase 4 | 2005-07-01 | This is an open-label pilot study of up to 1200 mg/day of carbamazepine ER (Equetro) in the treatment of children who meet DSM-IV criteria for Bipolar I, Bipolar II, or Bipolar Spectrum Disorder. The main goal of this study is to begin to address the void of information on safety, tolerability and effectiveness of Equetro in the treatment of Pediatric Bipolar Disorder. |
| NCT00181870 ↗ | Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder | Completed | Massachusetts General Hospital | Phase 4 | 2005-07-01 | This is an open-label pilot study of up to 1200 mg/day of carbamazepine ER (Equetro) in the treatment of children who meet DSM-IV criteria for Bipolar I, Bipolar II, or Bipolar Spectrum Disorder. The main goal of this study is to begin to address the void of information on safety, tolerability and effectiveness of Equetro in the treatment of Pediatric Bipolar Disorder. |
| NCT00203567 ↗ | Carbamazepine Extended-Release for the Treatment of Bipolar Depression | Completed | Shire | Phase 4 | 2005-08-01 | 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. |
| NCT00203567 ↗ | Carbamazepine Extended-Release for the Treatment of Bipolar Depression | Completed | Tuscaloosa Research & Education Advancement Corporation | Phase 4 | 2005-08-01 | 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. |
| NCT00325286 ↗ | Open Label Study of Lithium Plus Extended-Release Carbamazepine (ERC-CBZ) for Rapid Cycling Bipolar Disorder | Unknown status | Shire | Phase 4 | 2006-05-01 | 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. |
| NCT00325286 ↗ | Open Label Study of Lithium Plus Extended-Release Carbamazepine (ERC-CBZ) for Rapid Cycling Bipolar Disorder | Unknown status | Creighton University | Phase 4 | 2006-05-01 | 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. |
| NCT02623504 ↗ | DB/Maintenance of Equetro (Carbamazepine) in Children With Acute Manic or Mixed Bipolar 1 Disorder | Recruiting | Validus Pharmaceuticals | Phase 4 | 2016-01-01 | A phase 4 unequal randomization, double blind study to evaluate the dose tolerance and safety of extended release Equetro (carbamazepine) versus placebo followed by an Open label and long term maintenance treatment in children and adolescents aged 10-17 years diagnosed with acute manic or mixed Bipolar I Disorder |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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