Bipolar Study in Adults at Least 18 Years of Age

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: September 3, 2003
Last updated: October 11, 2012
Last verified: October 2012
Bipolar study of tolerability, clinical response and patient satisfaction

Condition Intervention Phase
Bipolar Disorder
Drug: lamotrigine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The primary endpoint will be the rate of rash during 12 weeks. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1200
Study Start Date: August 2003
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Open label single arm study
Drug: lamotrigine


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00067938

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Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00067938     History of Changes
Other Study ID Numbers: SCA40917 
Study First Received: September 3, 2003
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
bipolar disorder

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers processed this record on August 29, 2016