Oceanside, California 92056

  • Schizophrenia

Purpose:

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.


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 is Available At:


Original ID:

SCA30926


NCT ID:

NCT00071747


Secondary ID:


Study Acronym:


Brief Title:

Clinical Study Of Schizophrenia in Both Men and Women


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

GlaxoSmithKline


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

176


Enrollment Type:


Overall Contact Information

Official Name:GSK Clinical Trials
Study Director
GlaxoSmithKline

Study Dates

Start Date:August 2003
Completion Date:January 2005
Completion Type:Actual
Verification Date:August 2016
Last Changed Date:August 30, 2016
First Received Date:October 30, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:lamotrigine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:GlaxoSmithKline

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Goff DC, Keefe R, Citrome L, Davy K, Krystal JH, Large C, Thompson TR, Volavka J, Webster EL. Lamotrigine as add-on therapy in schizophrenia: results of 2 placebo-controlled trials. J Clin Psychopharmacol. 2007 Dec;27(6):582-9.
PMID:18004124

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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