Study Of An FDA-Approved Drug As Additional Therapy In Patients With Schizophrenia

Condition(s) targeted: Schizophrenia

Intervention: lamotrigine (Drug)

Phase: Phase 3

Status: No longer recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, Affiliation: GlaxoSmithKline

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.

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 design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.

Secondary outcome: - 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

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Starting date: April 2004
Last updated: January 9, 2006