Completed

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

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What is being tested

Data Collection

Who is being recruted

Mental Disorders

+ Schizophrenia

+ Schizophrenia Spectrum and Other Psychotic Disorders

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorGlaxoSmithKline
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

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 TitleA 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 
Principal SponsorGlaxoSmithKline
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

209 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSchizophreniaSchizophrenia Spectrum and Other Psychotic Disorders

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 39 locations

Suspended

GSK Investigational Site

Little Rock, United StatesSee the location
Suspended

GSK Investigational Site

Garden Grove, United States
Suspended

GSK Investigational Site

Glendale, United States
Suspended

GSK Investigational Site

Los Angeles, United States
Completed39 Study Centers