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.

Condition	Treatment or Intervention	Phase
Schizophrenia	Drug: Lamictal	Phase III

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• Aged 18-65 years
• 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.

Arkansas
      Little Rock,  Arkansas,  72211,  United States; Not yet recruiting
California
      Los Angeles,  California,  90033,  United States; Not yet recruiting
      Pico Rivera,  California,  90660,  United States; Recruiting
      Anaheim,  California,  91206,  United States; Not yet recruiting
      Sherman Oaks,  California,  91403,  United States; Recruiting
      San Diego,  California,  92123,  United States; Not yet recruiting
      San Diego,  California,  92126,  United States; Recruiting
      Sacramento,  California,  95823,  United States; Recruiting
      Garden Grove,  California,  97845,  United States; Recruiting
Florida
      Jacksonville,  Florida,  32216,  United States; Recruiting
      Winter Park,  Florida,  32789,  United States; Recruiting
      Winter Park,  Florida,  32789,  United States; Recruiting
      Miami,  Florida,  33125,  United States; Recruiting
      North Miami,  Florida,  33161,  United States; Recruiting
      West Palm Beach,  Florida,  33407,  United States; Not yet recruiting
Illinois
      Oak Brook,  Illinois,  60523,  United States; Recruiting
      Chicago,  Illinois,  60631,  United States; Recruiting
Indiana
      Greenwood,  Indiana,  46143,  United States; Not yet recruiting
      Indianapolis,  Indiana,  46202,  United States; Terminated
      Indianapolis,  Indiana,  46202,  United States; Not yet recruiting
New York
      Staten Island,  New York,  10305,  United States; Recruiting
South Carolina
      Charleston,  South Carolina,  29407,  United States; Terminated
Tennessee
      Nashville,  Tennessee,  37212,  United States; Not yet recruiting
Texas
      Bellaire,  Texas,  77401,  United States; Recruiting
      San Antonio,  Texas,  78229,  United States; Not yet recruiting
Wisconsin
      Madison,  Wisconsin,  53719,  United States; Not yet recruiting

Study ID Numbers:  101464
Record last reviewed:  October 2004
Record first received:  July 6, 2004
ClinicalTrials.gov Identifier:  NCT00086593
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10