Bipolar Disorder Study for Men and Women

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00056277
First received: March 10, 2003
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder


Condition Intervention Phase
Bipolar Disorder
Drug: lamotrigine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Bipolar Disorder Patients Currently Experiencing a Major Depressive Episode

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 Weeks ]

Secondary Outcome Measures:
  • Change from baseline scores at Week 8 for the Hamilton Depression Rating Scale (HAMD-17, HAMD-31, Bech Melancholia Scale (BMS), and HAMD - Item 1), Clinical Global Impressions of Severity (CGI-S) and Improvement (CGI-I). [ Time Frame: 8 Weeks ]

Enrollment: 260
Study Start Date: February 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: lamotrigine
    Other Name: lamotrigine
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must provide written and informed consent
  • Diagnosis of Bipolar I Disorder and currently depressed for minimum of the previous 8 weeks
  • Patients must have been hospitalized for mood disorder or incarceration with or without formal charges as the result of mania related behavior

Exclusion Criteria:

  • Patients must not be suicidal
  • Patients must not have a history or non-response to antidepressant treatment
  • Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry
  • Patients must not have had epilepsy or hypothyroidism
  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 ClinicalTrials.gov identifier: NCT00056277

Locations
United States, California
GSK Investigational Site
Beverly Hills, California, United States, 90210
GSK Investigational Site
La Jolla, California, United States, 92093
GSK Investigational Site
San Diego, California, United States, 92108
GSK Investigational Site
Santa Ana, California, United States, 92705
United States, Georgia
GSK Investigational Site
Marietta, Georgia, United States, 30060
United States, Indiana
GSK Investigational Site
Terre Haute, Indiana, United States, 47802
United States, Louisiana
GSK Investigational Site
Shreveport, Louisiana, United States, 71101
United States, Missouri
GSK Investigational Site
St. Charles, Missouri, United States, 63301
United States, New Jersey
GSK Investigational Site
Princeton, New Jersey, United States, 08540
United States, New York
GSK Investigational Site
New York, New York, United States, 10021
GSK Investigational Site
Pleasantville, New York, United States, 10570
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
GSK Investigational Site
Brecksville, Ohio, United States, 44141
GSK Investigational Site
Cincinnati, Ohio, United States, 45242
GSK Investigational Site
Cleveland, Ohio, United States, 44106
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29201
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States
United States, Wisconsin
GSK Investigational Site
Brown Deer, Wisconsin, United States, 53223
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00056277     History of Changes
Other Study ID Numbers: SCA30924
Study First Received: March 10, 2003
Last Updated: March 25, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Anticonvulsants
Lamotrigine
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 20, 2014