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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: lamotrigine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00086593

101464

Details and patient eligibility

About

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.

Enrollment

209 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.