Clinical trial NCT00086593: Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: adjunctive
atypical antipsychotics
add-on
Schizophrenia
psychosis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2004-07-08
Enrollment: 209
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: This is a 12-week study for the treatment of chronic persistent symptoms in participants with schizophrenia. Participants on a stable, optimal dose of up to two atypical antipsychotics who fulfill the screening criteria will be randomized to receive either an FDA-approved drug or placebo in addition to the current treatment. Safety will be closely monitored through vital signs, various tests, and blood and urine samples.


Eligibility criteria: Inclusion criteria:

* Diagnosed with schizophrenia.
* Exhibits persistent positive symptoms that have persisted for a minimum of 3 months prior to screening.
* Continuously taking 1-2 specific atypical antipsychotics for a minimum of 3 months and must be on a stable dose for at least 1 month prior to entering the study.
* Participant or a legal guardian is able to understand and sign the consent form.

Exclusion criteria:

* PANSS (Positive and Negative Syndrome Score) total score increases or decreases by more than 20% between the Screening and Baseline visits.
* Predominant Axis I disorder other than schizophrenia within 6 months prior to screening.
* History of clinically significant or unstable medical disorder or treatment that would interfere with the study.
* History of autistic disorder or another pervasive developmental disorder, organic brain disease, dementia, stroke, epilepsy or a history of seizures requiring treatment (this does not include febrile seizures as a child), or those who have suffered a traumatic head injury.
* Taking psychotropic or primarily centrally active medication at screening.
* Use of antidepressant medications or mood stabilizers within 1 month of screening.

Primary outcomes:
measure: Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.
timeFrame: 12 Weeks
Secondary outcomes:
measure: - Efficacy - Change from baseline in PANSS positive symptoms at Week 12 - Change from baseline in the Scale for the Assessment of Negative Symptoms (SANS) at Week 12 - Change from baseline in PANSS general psychopathology symptoms 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: Glendale
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Pico Rivera
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Sherman Oaks
country: United States
facility: GSK Investigational Site
state: California
city: Coral Springs
country: United States
facility: GSK Investigational Site
state: Florida
city: Maitland
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: North Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Winter Park
country: United States
facility: GSK Investigational Site
state: Florida
city: Niles
country: United States
facility: GSK Investigational Site
state: Illinois
city: Oak Brook
country: United States
facility: GSK Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Staten Island
country: United States
facility: GSK Investigational Site
state: New York
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Bellaire
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Miramichi
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Dartmouth
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Sydney
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Burlington
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Bedford
country: United Kingdom
facility: GSK Investigational Site
state: Bedfordshire
city: Cambridge
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Coventry
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: Hull
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: