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

GlaxoSmithKline1 site in 1 country209 target enrollmentMay 2004

ConditionsSchizophrenia

Drugslamotrigine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: GlaxoSmithKline
Enrollment: 209
Locations: 1
Primary Endpoint: Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

May 2004

End Date

July 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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)