SchizophreniaPhase 3NCT00086593
Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia
A Phase 3 study testing lamotrigine in people with Schizophrenia, run by GlaxoSmithKline at 39 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- lamotrigine
- How many people
- 209 participants
- Where
- 39 sitesin 3 countries
- Study dates
- May 2004to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
39 sites in 3 countries.
39 sites in 3 countries
United States21 sites
GSK Investigational Site
Bellaire, Texas, 77401
GSK Investigational Site
Coral Springs, Florida, 33065
GSK Investigational Site
Garden Grove, California, 92845
GSK Investigational Site
Glendale, California, 91206
GSK Investigational Site
Indianapolis, Indiana, 46202-5200
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Little Rock, Arkansas, 72201
GSK Investigational Site
Los Angeles, California, 90033
GSK Investigational Site
Madison, Wisconsin, 53711-2027
GSK Investigational Site
Maitland, Florida, 32751
GSK Investigational Site
Miami, Florida, 33125
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
Niles, Illinois, 60714
GSK Investigational Site
North Miami, Florida, 33161
GSK Investigational Site
Oak Brook, Illinois, 60523
GSK Investigational Site
Pico Rivera, California, 90660
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92126
GSK Investigational Site
Sherman Oaks, California, 91403
GSK Investigational Site
Staten Island, New York, 10305
GSK Investigational Site
Winter Park, Florida, 32789
Canada13 sites
GSK Investigational Site
Burlington, Ontario, L7N 3V2
GSK Investigational Site
Dartmouth, Nova Scotia, B2Y 3S3
GSK Investigational Site
Edmonton, Alberta, T5K 2J5
GSK Investigational Site
Edmonton, Alberta, T6G 2C8
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1X3
GSK Investigational Site
Kelowna, British Columbia, V1W 4V5
GSK Investigational Site
London, Ontario, N6A 4G5
GSK Investigational Site
Miramichi, New Brunswick, E1V 3G5
GSK Investigational Site
Mississauga, Ontario, L5M 4N4
GSK Investigational Site
Sydney, Nova Scotia, B1S 2E8
GSK Investigational Site
Toronto, Ontario, M6M 3Z5
GSK Investigational Site
Windsor, Ontario, N9C 3Z4
GSK Investigational Site
Winnipeg, Manitoba, R3E 3N4
United Kingdom5 sites
GSK Investigational Site
Bedford, Bedfordshire, MK42 9DJ
GSK Investigational Site
Cambridge, Cambridgeshire, CB1 5EF
GSK Investigational Site
Coventry, Warwickshire, CV2 2DX
GSK Investigational Site
Glasgow, Lanarkshire, G66 3UG
GSK Investigational Site
Hull, HU6 7RX
About this 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
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.
- Conditions
- Schizophrenia
- Being tested
- lamotrigine
- Keywords
- adjunctive, atypical antipsychotics, add-on, Schizophrenia, psychosis
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lamotrigineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.
Measured: 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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2004 (estimated)
- Study startMay 2004
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086593
- Sponsor's protocol ID
- 101464
- Status last verified
- Oct 2016
- First submitted
- 6 Jul 2004
- Last updated
- 7 Oct 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00086593
- Acronym / sponsor ID
- 101464
- Conditions
- Schizophrenia
- Keywords
- adjunctive, atypical antipsychotics, add-on, Schizophrenia, psychosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 8 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lamotrigine | Drug | – |
Primary outcome
Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.
Time frame: 12 Weeks
1 secondary outcome
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
39 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lamotrigine in people with Schizophrenia, run by GlaxoSmithKline at 39 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12. (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.