Clinical trial NCT00071747: Clinical Study Of Schizophrenia in Both Men and Women
Official title: A Multi-Center, Double Blind, Placebo-controlled, Randomized, Parallel Group Evaluation of the Efficacy of a Flexible Dose of Lamotrigine Versus Placebo As Add-On Therapy In Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: schizophrenia
lamotrigine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2003-10-31
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effectiveness of a marketed drug in the treatment of schizophrenia, as an add-on therapy to antipsychotics over a 12-week period. Subjects with schizophrenia who have been maintained on a stable dose of antipsychotics and who fulfill the screening entrance criteria will have an assessment 1-7 days after the first visit to confirm eligibility.


Eligibility criteria: Inclusion criteria:

* If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.
* Diagnosis of Schizophrenia
* Patients must be taking clozapine monotherapy or other atypical antipsychotic at least 3 months prior to this study.

Exclusion criteria:

* Patients who are currently taking or have taken antidepressant medication in the last month prior.
* Patients who are or have been suicidal or homicidal in the last 6 months.
* Patients with a history of autistic disorder or another pervasive developmental disorder
* Patients whose condition is due to the direct physiological effects of a substance (e.g. a drug of abuse, a medication) or a general medical condition

Primary outcomes:
measure: Change from baseline in the total score of the 7 items of the Positive and Negative Symptom Scale (PANSS) positive symptom subscale for lamotrigine vs. placebo at Week 12.
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change from baseline in the PANSS total score at Week 12; Change from baseline in the Scale for the Assessment of Negative Symptoms (SANS) at Week 12; Change from baseline in the Clinical Global Impression-Severity of Illness (CGI-S) score at Week 12.
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Garden Grove
country: United States
facility: GSK Investigational Site
state: California
city: La Mesa
country: United States
facility: GSK Investigational Site
state: California
city: National City
country: United States
facility: GSK Investigational Site
state: California
city: Oceanside
country: United States
facility: GSK Investigational Site
state: California
city: Rosemead
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Hartford
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Maitland
country: United States
facility: GSK Investigational Site
state: Florida
city: North Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Granite City
country: United States
facility: GSK Investigational Site
state: Illinois
city: Glen Burnie
country: United States
facility: GSK Investigational Site
state: Maryland
city: Rockville
country: United States
facility: GSK Investigational Site
state: Maryland
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Reno
country: United States
facility: GSK Investigational Site
state: Nevada
city: Clementon
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Kenilworth
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Orangeburg
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Butner
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Lyndhurst
country: United States
facility: GSK Investigational Site
state: Ohio
city: Norristown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Bellaire
country: United States
facility: GSK Investigational Site
state: Texas
city: DeSoto
country: United States
facility: GSK Investigational Site
state: Texas
city: Midvale
country: United States
facility: GSK Investigational Site
state: Utah
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Goff DC, Keefe R, Citrome L, Davy K, Krystal JH, Large C, Thompson TR, Volavka J, Webster EL. Lamotrigine as add-on therapy in schizophrenia: results of 2 placebo-controlled trials. J Clin Psychopharmacol. 2007 Dec;27(6):582-9. doi: 10.1097/jcp.0b013e31815abf34.