Bipolar Disorder Clinical Trial
Official title:
Lamictal for Use in Treatment of Bipolar Disorder In Adults. A Practical Clinical Assessment of Tolerability and Clinical Effectiveness.
| Verified date | August 2016 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Bipolar study of tolerability, clinical response and patient satisfaction
| Status | Completed |
| Enrollment | 1200 |
| Est. completion date | August 2004 |
| Est. primary completion date | August 2004 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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| United States | GSK Investigational Site | Adrian | Michigan |
| United States | GSK Investigational Site | Albany | New York |
| United States | GSK Investigational Site | Albertville | Alabama |
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| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary endpoint will be the rate of rash during 12 weeks. | 12 Weeks | No | |
| Secondary | Change from baseline in Week 5 and Week 12 Clinical Global Impression-Bipolar version (CGI-BP) Severityand Improvement scores. | 12 Weeks | No |
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