Clinical Study Of Schizophrenia in Both Men and Women

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: lamotrigine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00071747

SCA30926

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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