Full Text View
Tabular View
No Study Results Posted
Related Studies
Study Of An FDA-Approved Drug As Additional Therapy In Patients With Schizophrenia
This study has been completed.
First Received: July 6, 2004   Last Updated: May 15, 2009   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00086593
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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:


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
  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, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 101464
Study First Received: July 6, 2004
Last Updated: May 15, 2009
ClinicalTrials.gov Identifier: NCT00086593     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Tranquilizing Agents
Psychotropic Drugs
Central Nervous System Depressants
Calcium Channel Blockers
Cardiovascular Agents
Antipsychotic Agents
Schizophrenia
Calcium, Dietary
Mental Disorders
Lamotrigine
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Anticonvulsants

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

ClinicalTrials.gov processed this record on July 02, 2009