A Clinical Evaluation Of BW430C (Lamotrigine) In Bipolar I Disorder- Long-term Extension Of Study SCA104779 (NCT00550407) -

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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 (NCT00550407)), 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Anticonvulsants; Lamotrigine

Criteria

Inclusion Criteria:

• Of subjects participating in the preceding double-blind study, those who are judged by the investigator/sub-investigator to have well tolerated the double-blind treatment and to be eligible for the 52-week extension treatment

• Sex: either sex. Female of child-bearing potential will be eligible for inclusion in this study. However they have to have a negative pregnancy test at the start of this study, agree to further pregnancy testing at the time points determined in study assessments and procedures and practice one of the following methods of contraception from the start of this study until the end of the follow-up examination:

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)

• In/Out patient: Either

• Informed consent: the subject capable of giving written informed consent

Exclusion Criteria:

• Has a score of 3 or more on item of the HAM-D related to suicide or is at a high suicidal risk in the judgment of the investigator/sub-investigator

• Has a history of severe rash or rash due to anti-epileptic drugs

• Patients with severe hepatic/renal/cardiac/pulmonary disorder or hematopoietic disorder. The severity refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences" (PAB/SD Notification No. 80, dated 29 June 1992)

• Patients have less than 5 years of remission history from clinically significant malignancy (other than e.g. basal cell or squamous cell skin cancer, in-situ carcinoma of cervix or prostate CA in situ)

• Patients with chronic hepatitis typeB and /or typeC which is positive of hepatitis B surface antigen （HBsAg）and/or hepatitis C antibody

• Has an acute or chronic illness likely to impair drug absorption, distribution, metabolism or excretion or has any unstable physical symptoms likely to require hospitalisation during participation in the study

• Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study

• Has a history or current diagnosis of epilepsy

• Has received an investigational drug within 30 days of screening

• Patients with a history of drug allergy to any ingredient of the test-drug

• Patients whom the investigator or sub-investigator considers ineligible for the study