Last updated: 11/06/2018 23:36:20
Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.
Timeframe: 12 Weeks
Secondary outcomes:
- 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.
Timeframe: 12 Weeks
Interventions:
Drug: lamotrigine
Enrollment:
209
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Donald C. Goff, MD Richard Keefe, PhD Leslie Citrome, MD Katherine Davy, MSc John Krystal, MD Charles Large, PhD Jan Volavka, MD Elizabeth L. Webster, PhD . Lamotrigine as Add-on Therapy in Schizophrenia: Results of Two Placebo-Controlled Trials. J Clin Psychopharmacol. 2007;27(6):582-589.
Medical condition
Schizophrenia
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
May 2004 to July 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Diagnosed with schizophrenia.
- Exhibits persistent positive symptoms that have persisted for a minimum of 3 months prior to screening.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Dartmouth, Nova Scotia, Canada, B2Y 3S3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Diego, California, United States, 92126
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Maitland, Florida, United States, 32751
Status
Study Complete
Location
GSK Investigational Site
Garden Grove, California, United States, 92845
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Glendale, California, United States, 91206
Status
Study Complete
Location
GSK Investigational Site
Coral Springs, Florida, United States, 33065
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53711-2027
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pico Rivera, California, United States, 90660
Status
Study Complete
Location
GSK Investigational Site
North Miami, Florida, United States, 33161
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Niles, Illinois, United States, 60714
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Miramichi, New Brunswick, Canada, E1V 3G5
Status
Study Complete
Location
GSK Investigational Site
Kelowna, British Columbia, Canada, V1W 4V5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 2C8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Angeles, California, United States, 90033
Status
Study Complete
Location
GSK Investigational Site
Coventry, Warwickshire, United Kingdom, CV2 2DX
Status
Study Complete
Location
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
Status
Study Complete
Location
GSK Investigational Site
Winter Park, Florida, United States, 32789
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB1 5EF
Status
Study Complete
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G66 3UG
Status
Study Complete
Location
GSK Investigational Site
Sherman Oaks, California, United States, 91403
Status
Study Complete
Location
GSK Investigational Site
Staten Island, New York, United States, 10305
Status
Study Complete
Location
GSK Investigational Site
Bedford, Bedfordshire, United Kingdom, MK42 9DJ
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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