Schizophrenia
Conditions
Keywords
schizophrenia, lamotrigine
Brief summary
The objective of this study is to evaluate the effectiveness of a marketed drug in the treatment of schizophrenia, as an add-on therapy to antipsychotics over a 12-week period. Subjects with schizophrenia who have been maintained on a stable dose of antipsychotics and who fulfill the screening entrance criteria will have an assessment 1-7 days after the first visit to confirm eligibility.
Interventions
DRUGlamotrigine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception. * Diagnosis of Schizophrenia * Patients must be taking clozapine monotherapy or other atypical antipsychotic at least 3 months prior to this study.
Exclusion criteria
* Patients who are currently taking or have taken antidepressant medication in the last month prior. * Patients who are or have been suicidal or homicidal in the last 6 months. * Patients with a history of autistic disorder or another pervasive developmental disorder * Patients whose condition is due to the direct physiological effects of a substance (e.g. a drug of abuse, a medication) or a general medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the total score of the 7 items of the Positive and Negative Symptom Scale (PANSS) positive symptom subscale for lamotrigine vs. placebo at Week 12. | 12 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the PANSS total score at Week 12; Change from baseline in the Scale for the Assessment of Negative Symptoms (SANS) at Week 12; Change from baseline in the Clinical Global Impression-Severity of Illness (CGI-S) score at Week 12. | 12 Weeks |
Countries
United States
Outcome results
None listed