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| Descriptive Information Fields | |||||
| Brief Title † | A Clinical Evaluation Of BW430C (Lamotrigine) In Bipolar I Disorder - Long-Term Extension Of Study SCA104779 - | ||||
| Official Title † | Study SCA106052, a Clinical Evaluation of BW430C (Lamotrigine) in Bipolar I Disorder - Long-Term Extension Study (Extension of Study SCA104779) - | ||||
| Brief Summary | This study is planned to assess the long-term safety of lamotrigine in Japanese patients with bipolar I disorder who will continue into the 52-week extension upon completion of a double-blind comparative study (Study No.: SCA104779), i.e. the patients who receive the addition of any additional treatment to intervene in a mood episode in the double-blind phase or the patients completing the double-blind phase. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study | ||||
| Primary Outcome Measure † | - Adverse events at every visit - Abnormality of clinical laboratory test values at Week0, Week6, Week16, Week28, Week 40 and Week 52 - Vital signs at every visit - Electrocardiogram at Week0, Week6, Week28 and Week 52 | ||||
| Secondary Outcome Measure † | - CGI-S at every visit
- HAM-D at Week0, Week6, Week16, Week28, Week 40 and Week 52
- YMRS at Week0, Week6, Week16, Week28, Week 40 and Week 52
- Serum lamotrigine concentrations at Week6, Week16, Week28, Week 40 and Week 52 [ Time Frame: Week 52 ] Change from baseline of Clinical Global Impressions of Severity (CGI-S); Change from baseline of Hamilton Depression Rating Scale (HAM-D); Change from baseline of Young Mania Rating Scale (YMRS); |
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| Condition † | Bipolar Disorder | ||||
| Intervention † | Drug: BW430C (lamotrigine) | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 63 | ||||
| Start Date † | May 2008 | ||||
| Completion Date | December 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Abstinence Oral contraceptive, either combined or progestogen alone (except during the Dosage Adjustment Phase) Injectable progestogen Implants of levonorgestrel Estrogenic vaginal ring (except during the Dosage Adjustment Phase) Percutaneous contraceptive patches (except during the Dosage Adjustment Phase) Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus spermicidal agent (foam / gel / film / cream / suppository)
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | Japan | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00566020 | ||||
| Organization ID | SCA106052 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | GlaxoSmithKline | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | November 2008 | ||||
| First Received Date † | November 28, 2007 | ||||
| Last Updated Date | November 19, 2008 | ||||