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OpenTrials
Completed

NCT Number: NCT00086593

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lamotrigine

Drug

Primary outcomes

  1. Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.

    Time frame: 12 Weeks

Secondary outcomes

  1. - 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jul 8, 2004
Registry last updated
Oct 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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