Bipolar Disorder
Conditions
Keywords
bipolar disorder, lamotrigine
Brief summary
Bipolar study of tolerability, clinical response and patient satisfaction
Interventions
DRUGlamotrigine
Lamotrigine
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of bipolar I disorder. * Must be on a stable regimen of psychiatric medication for at least 2 months prior to study. * If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.
Exclusion criteria
* Patients with a clinically significant psychiatric or physiologic comorbidity including significant substance abuse, depression or mania which is of an unstable of progressive nature that could interfere in participation of this study. * Presence of untreated thyroid disease. * Patient is actively suicidal or homicidal. * Patient has history of severe hepatic or renal insufficiency. * Patient is currently participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the rate of rash during 12 weeks. | 12 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Week 5 and Week 12 Clinical Global Impression-Bipolar version (CGI-BP) Severityand Improvement scores. | 12 Weeks |
Countries
United States
Outcome results
None listed