Clinical Study Of Schizophrenia in Both Men and Women
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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.
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. [ Time Frame: 12 Weeks ]
Secondary Outcome Measures
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. [ Time Frame: 12 Weeks ]
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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