NCT00086593CompletedPhase 3
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 209
- Locations
- 39
- Primary Endpoint
- Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.
Time Frame: 12 Weeks
Secondary Outcomes
- - 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.(12 Weeks)
Investigators
Study Sites (39)
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