Overview

Clinical Study Of Schizophrenia in Both Men and Women

Status:
Completed
Trial end date:
2005-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Anticonvulsants
Lamotrigine
Criteria
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