Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-27 @ 4:09 PM
Study NCT ID:
NCT00086593
Status:
COMPLETED
Last Update Posted:
2016-10-07
First Post:
2004-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
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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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Diagnosed with schizophrenia.\n* Exhibits persistent positive symptoms that have persisted for a minimum of 3 months prior to screening.\n* 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.\n* Participant or a legal guardian is able to understand and sign the consent form.\n\nExclusion criteria:\n\n* PANSS (Positive and Negative Syndrome Score) total score increases or decreases by more than 20% between the Screening and Baseline visits.\n* Predominant Axis I disorder other than schizophrenia within 6 months prior to screening.\n* History of clinically significant or unstable medical disorder or treatment that would interfere with the study.\n* 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.\n* Taking psychotropic or primarily centrally active medication at screening.\n* Use of antidepressant medications or mood stabilizers within 1 month of screening.'}, 'identificationModule': {'nctId': 'NCT00086593', 'briefTitle': 'Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': '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', 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