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Depression And Bipolar Disorder
This study has been completed.
Study NCT00274677   Information provided by GlaxoSmithKline
First Received: January 9, 2006   Last Updated: May 29, 2009   History of Changes

January 9, 2006
May 29, 2009
November 2003
August 2005   (final data collection date for primary outcome measure)
Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS)
Complete list of historical versions of study NCT00274677 on ClinicalTrials.gov Archive Site
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 ]
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).
 
Depression And Bipolar Disorder
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

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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Bipolar Disorder
  • Drug: lamotrigine
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
221
August 2005
August 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00274677
Study Director, GSK
SCA100223
GlaxoSmithKline
 
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP