DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Clinical Study Of Schizophrenia in Both Men and Women

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: lamotrigine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change from baseline in the total score of the 7 items of the Positive and Negative Symptom Scale (PANSS) positive symptom subscale for lamotrigine vs. placebo at Week 12.

Secondary outcome: Change from baseline in the PANSS total score at Week 12; Change from baseline in the Scale for the Assessment of Negative Symptoms (SANS) at Week 12; Change from baseline in the Clinical Global Impression-Severity of Illness (CGI-S) score at Week 12.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

GSK Investigational Site, Little Rock, Arkansas 72201, United States

GSK Investigational Site, Garden Grove, California 92845, United States

GSK Investigational Site, La Mesa, California 91942, United States

GSK Investigational Site, National City, California 91950, United States

GSK Investigational Site, Oceanside, California 92056, United States

GSK Investigational Site, Rosemead, California 91770, United States

GSK Investigational Site, San Diego, California 92126, United States

GSK Investigational Site, Hartford, Connecticut 06106, United States

GSK Investigational Site, Maitland, Florida 32751, United States

GSK Investigational Site, North Miami, Florida 33161, United States

GSK Investigational Site, Granite City, Illinois 62040, United States

GSK Investigational Site, Glen Burnie, Maryland 21061, United States

GSK Investigational Site, Rockville, Maryland 20852, United States

GSK Investigational Site, Boston, Massachusetts 02114, United States

GSK Investigational Site, Reno, Nevada 89512, United States

GSK Investigational Site, Clementon, New Jersey 08021, United States

GSK Investigational Site, Kenilworth, New Jersey 07033, United States

GSK Investigational Site, Orangeburg, New York 10962, United States

GSK Investigational Site, Rochester, New York 14620, United States

GSK Investigational Site, Butner, North Carolina 27509, United States

GSK Investigational Site, Charlotte, North Carolina 28211, United States

GSK Investigational Site, Raleigh, North Carolina 27603, United States

GSK Investigational Site, Raleigh, North Carolina 27609, United States

GSK Investigational Site, Beachwood, Ohio 44122, United States

GSK Investigational Site, Cleveland, Ohio 44106, United States

GSK Investigational Site, Lyndhurst, Ohio 44124, United States

GSK Investigational Site, Norristown, Pennsylvania 19401, United States

GSK Investigational Site, Austin, Texas 78756, United States

GSK Investigational Site, Bellaire, Texas 77401, United States

GSK Investigational Site, DeSoto, Texas 75115, United States

GSK Investigational Site, Midvale, Utah 84047, United States

GSK Investigational Site, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: August 2003
Last updated: October 4, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017