Bipolar Study in Adults at Least 18 Years of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00067938
Recruitment Status : Completed
First Posted : September 5, 2003
Last Update Posted : September 1, 2016
Information provided by (Responsible Party):

September 3, 2003
September 5, 2003
September 1, 2016
August 2003
August 2004   (Final data collection date for primary outcome measure)
The primary endpoint will be the rate of rash during 12 weeks. [ Time Frame: 12 Weeks ]
Not Provided
Complete list of historical versions of study NCT00067938 on Archive Site
Change from baseline in Week 5 and Week 12 Clinical Global Impression-Bipolar version (CGI-BP) Severityand Improvement scores. [ Time Frame: 12 Weeks ]
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Bipolar Study in Adults at Least 18 Years of Age
Lamictal for Use in Treatment of Bipolar Disorder In Adults. A Practical Clinical Assessment of Tolerability and Clinical Effectiveness.
Bipolar study of tolerability, clinical response and patient satisfaction
Not Provided
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bipolar Disorder
Drug: lamotrigine
Arm 1
Open label single arm study
Intervention: Drug: lamotrigine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2004
August 2004   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through following the timelines and process described on this site.
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Study Director: GSK Clinical Trials GlaxoSmithKline
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP