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

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: lamotrigine	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12. [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:

- 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. [ Time Frame: 12 Weeks ]


Enrollment:	209
Study Start Date:	May 2004
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Diagnosed with schizophrenia.
Exhibits persistent positive symptoms that have persisted for a minimum of 3 months prior to screening.
Continuously taking 1-2 specific atypical antipsychotics for a minimum of 3 months and must be on a stable dose for at least 1 month prior to entering the study.
Participant or a legal guardian is able to understand and sign the consent form.

Exclusion criteria:

PANSS (Positive and Negative Syndrome Score) total score increases or decreases by more than 20% between the Screening and Baseline visits.
Predominant Axis I disorder other than schizophrenia within 6 months prior to screening.
History of clinically significant or unstable medical disorder or treatment that would interfere with the study.
History of autistic disorder or another pervasive developmental disorder, organic brain disease, dementia, stroke, epilepsy or a history of seizures requiring treatment (this does not include febrile seizures as a child), or those who have suffered a traumatic head injury.
Taking psychotropic or primarily centrally active medication at screening.
Use of antidepressant medications or mood stabilizers within 1 month of screening.

Contacts and Locations

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: NCT00086593

Show 39 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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