Clinical trial NCT00056277: Bipolar Disorder Study for Men and Women
Official title: Double Blind Placebo Controlled Study of Lamictal in Acute Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2003-03-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 8 Weeks
Secondary outcomes:
measure: 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).
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: GSK Investigational Site
state: California
city: La Jolla
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Santa Ana
country: United States
facility: GSK Investigational Site
state: California
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Terre Haute
country: United States
facility: GSK Investigational Site
state: Indiana
city: Shreveport
country: United States
facility: GSK Investigational Site
state: Louisiana
city: St. Charles
country: United States
facility: GSK Investigational Site
state: Missouri
city: Princeton
country: United States
facility: GSK Investigational Site
state: New Jersey
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Pleasantville
country: United States
facility: GSK Investigational Site
state: New York
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Brecksville
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Eugene
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Brown Deer
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Hashimoto Y, Kotake K, Watanabe N, Fujiwara T, Sakamoto S. Lamotrigine in the maintenance treatment of bipolar disorder. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD013575. doi: 10.1002/14651858.CD013575.pub2.