A Multi-Center, Double Blind, Placebo-controlled, Randomized, Parallel Group Evaluation of the Efficacy of a Flexible Dose of Lamotrigine Versus Placebo As Add-On Therapy In Schizophrenia
Data Collection
Mental Disorders
+ Schizophrenia
+ Schizophrenia Spectrum and Other Psychotic Disorders
Treatment Study
Summary
Study start date: August 1, 2003
Actual date on which the first participant was enrolled.The objective of this study is to evaluate the effectiveness of a marketed drug in the treatment of schizophrenia, as an add-on therapy to antipsychotics over a 12-week period. Subjects with schizophrenia who have been maintained on a stable dose of antipsychotics and who fulfill the screening entrance criteria will have an assessment 1-7 days after the first visit to confirm eligibility.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.176 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Inclusion criteria: * If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception. * Diagnosis of Schizophrenia * Patients must be taking clozapine monotherapy or other atypical antipsychotic at least 3 months prior to this study. Exclusion criteria: * Patients who are currently taking or have taken antidepressant medication in the last month prior. * Patients who are or have been suicidal or homicidal in the last 6 months. * Patients with a history of autistic disorder or another pervasive developmental disorder * Patients whose condition is due to the direct physiological effects of a substance (e.g. a drug of abuse, a medication) or a general medical condition
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.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 32 locations
GSK Investigational Site
Garden Grove, United StatesGSK Investigational Site
La Mesa, United StatesGSK Investigational Site
National City, United States