Lamictal Bipolar Observational Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00460226
First received: April 12, 2007
Last updated: March 15, 2012
Last verified: January 2011
  Purpose

This is multi-center, prospective, observational stud. This study is designed to evaluate the rate of non-serious rash in Korean bipolar I patients.


Condition Intervention
Bipolar Disorder
Drug: lamotrigine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Multi-centre, Observational Study to Evaluate the Incidence of Non-serious Rash in Korean Bipolar I Patients With Lamotrigine Therapy in Real World Setting

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of non-serious rash during 12 weeks of treatment with lamotrigine in patients with bipolar I in Korea [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • CGI-BP at Week 12 and occurrence of adverse events at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 238
Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
lamotrigine
there is only one group.
Drug: lamotrigine
lamotrigine treatment for 12weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patient setting and reflecting usual clinical practice in general hospital

Criteria

Inclusion criteria:

  • A subject will be eligible for inclusion in this study only if all of the following criteria apply:
  • Provides written informed consent
  • Male or female age 18 years or older A female subject is eligible to enter and participate in the study if she is of;
  • Non-childbearing potential
  • Childbearing potential, has a negative pregnancy test at screen
  • Diagnosis of bipolar I disorder using DSM-IV criteria

Exclusion criteria:

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • Previous or current treatment with lamotrigine
  • Presence of a clinically significant psychiatric or physiologic comorbidity, including significant substance abuse, severe depression or mania which is of an unstable or progressive nature that could, in the opinion of the investigator, interfere with participation in this study
  • Presence of untreated thyroid disease
  • Have active suicidality or homicidality, history of recent suicide attempts within the past year, or, in the investigator's opinion, a marked risk for suicide
  • History of severe hepatic or renal insufficiency or significant hematologic disease or other significant medical or psychiatric condition that would interfere with subjects' participation in the study
  • Currently participating in another clinical trial, or plans to enroll in another trial while participating in this study
  • Currently pregnant or is breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460226

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

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00460226     History of Changes
Other Study ID Numbers: LBI108245
Study First Received: April 12, 2007
Last Updated: March 15, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Korean
Bipolar I disorder
Non-serious rash
Lamotrigine

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lamotrigine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014