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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00086593
First received: July 6, 2004
Last updated: September 6, 2012
Last verified: August 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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:

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 ]

Estimated Enrollment: 210
Study Start Date: May 2004
Intervention Details:
    Drug: lamotrigine
    Other Name: lamotrigine
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086593

  Show 36 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00086593     History of Changes
Other Study ID Numbers: 101464
Study First Received: July 6, 2004
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
psychosis
atypical antipsychotics
adjunctive
Schizophrenia
add-on

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Lamotrigine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anticonvulsants

ClinicalTrials.gov processed this record on June 18, 2013