Trial record 13 of 852 for:
(psychotic disorders OR schizophrenia) AND (woman OR women OR female)
Clinical Study Of Schizophrenia in Both Men and Women
This study has been completed.
Information provided by:
First received: October 30, 2003
Last updated: October 4, 2010
Last verified: October 2010
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 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. [ Time Frame: 12 Weeks ]
Secondary Outcome Measures:
- 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. [ Time Frame: 12 Weeks ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2005 (Final data collection date for primary outcome measure)
Other Name: lamotrigine
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00071747
||GSK Clinical Trials, MD
No publications provided
||Study Director, GSK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 30, 2003
||October 4, 2010
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 26, 2015
Schizophrenia and Disorders with Psychotic Features
Calcium Channel Blockers
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sodium Channel Blockers
Voltage-Gated Sodium Channel Blockers