Depression And Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00274677
First received: January 9, 2006
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.


Condition Intervention Phase
Bipolar Disorder
Drug: Placebo
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 Major Depression in Patients With Type II Bipolar Disorder

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: Eight weeks ] [ Designated as safety issue: No ]

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: Eight weeks ] [ Designated as safety issue: No ]

Enrollment: 221
Study Start Date: November 2003
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: lamotrigine
Experimental treatment
Other Name: Placebo
Experimental: lamotrigine Drug: Placebo
Experimental treatment arm
Other Name: placebo

  Eligibility

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

Inclusion

  • Patients must provide written and informed consent.
  • Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks.

Exclusion

  • Patients must not be suicidal.
  • Patients must not have a history of 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: NCT00274677

Locations
United States, California
GSK Investigational Site
Burbank, California, United States, 91506
GSK Investigational Site
Loma Linda, California, United States, 92354
GSK Investigational Site
San Diego, California, United States, 92108
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
Clementon, New Jersey, United States, 08021
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
Charlotte, North Carolina, United States, 28209
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
GSK Investigational Site
Beachwood, Ohio, United States, 44122
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73118
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29201
United States, Texas
GSK Investigational Site
Galveston, Texas, United States, 77555-0188
GSK Investigational Site
Houston, Texas, United States, 77090
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00274677     History of Changes
Obsolete Identifiers: NCT00076882
Other Study ID Numbers: SCA100223
Study First Received: January 9, 2006
Last Updated: October 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Bipolar Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Disease
Affective Disorders, Psychotic
Behavioral Symptoms
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 29, 2014