Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00086593

Public ClinicalTrials.gov record NCT00086593. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 24, 2026, 3:26 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00086593
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
GlaxoSmithKline
Industry
Enrollment
209 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2004
Primary completion
Jun 30, 2005
Completion
Jun 30, 2005
Last update posted
Oct 6, 2016

2004 – 2005

United States locations

U.S. sites
21
U.S. states
9
U.S. cities
20
Facility City State ZIP Site status
GSK Investigational Site Little Rock Arkansas 72201 —
GSK Investigational Site Garden Grove California 92845 —
GSK Investigational Site Glendale California 91206 —
GSK Investigational Site Los Angeles California 90033 —
GSK Investigational Site Pico Rivera California 90660 —
GSK Investigational Site San Diego California 92126 —
GSK Investigational Site Sherman Oaks California 91403 —
GSK Investigational Site Coral Springs Florida 33065 —
GSK Investigational Site Maitland Florida 32751 —
GSK Investigational Site Miami Florida 33125 —
GSK Investigational Site North Miami Florida 33161 —
GSK Investigational Site Winter Park Florida 32789 —
GSK Investigational Site Niles Illinois 60714 —
GSK Investigational Site Oak Brook Illinois 60523 —
GSK Investigational Site Indianapolis Indiana 46202-5200 —
GSK Investigational Site Indianapolis Indiana 46202 —
GSK Investigational Site Staten Island New York 10305 —
GSK Investigational Site Nashville Tennessee 37203 —
GSK Investigational Site Bellaire Texas 77401 —
GSK Investigational Site San Antonio Texas 78229 —
GSK Investigational Site Madison Wisconsin 53711-2027 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00086593, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 6, 2016 · Synced Sep 24, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00086593 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →