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Bipolar Study in Adults at Least 18 Years of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00067938
First received: September 3, 2003
Last updated: August 31, 2016
Last verified: August 2016

September 3, 2003
August 31, 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00067938 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar Disorder
Drug: lamotrigine
Lamotrigine
Arm 1
Open label single arm study
Intervention: Drug: lamotrigine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00067938
SCA40917
No
Yes
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2016

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