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: October 11, 2012
Last verified: October 2012

September 3, 2003
October 11, 2012
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
An Open-label Study of Tolerability, Clinical Response, and Satisfaction in Adult Bipolar I Subjects Optimizing Initiation of Therapy Using Administration of Dermatological Precautions and LAMICTAL Titration Packs

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
Other Name: 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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00067938
SCA40917
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2012

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