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Bipolar Disorder Study for Men and Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00056277
First Posted: March 11, 2003
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind Placebo Controlled Study of Lamictal in Acute Bipolar Depression

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: 150
Study Start Date: February 27, 2003
Study Completion Date: December 14, 2005
Primary Completion Date: August 1, 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Drug: lamotrigine

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 77090
United States, Wisconsin
GSK Investigational Site
Brown Deer, Wisconsin, United States, 53223
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: SCA30924
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: SCA30924
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: SCA30924
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: SCA30924
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SCA30924
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SCA30924
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: SCA30924
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00056277     History of Changes
Other Study ID Numbers: SCA30924
First Submitted: March 10, 2003
First Posted: March 11, 2003
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Lamotrigine
Anticonvulsants
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