PEDRO V MAGALHAES, M.D., Ph.D.

CONTACT

Lead Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

•DSM-IV Bipolar I Disorder;
•having had a mood episode within the preceding year; DSM-IV rapid cyclers will be permitted to participate in this study;
•males or females between 18 and 65 years of age;
•ongoing illness symptoms including significant functional impairment;
•documented history of treatment resistance, defined as persistent symptoms despite simultaneous, adequate treatment with at least two medications: one mood stabilizer (lithium or valproate) + antipsychotic OR two mood stabilizers (at least one of them being lithium or valproate).
•each patient must have a level of understanding sufficient to agree to all the tests required by the protocol and must sign an informed consent document

•patients with onset of illness after age 40 or illness resulting from secondary causes
•women who are pregnant or breastfeeding, or not using adequate contraception
•unstable medical illnesses
•clinically significant abnormal laboratory tests
•current active alcohol or substance abuse
•severe personality disorders
•contraindication to the use of clozapine or previous treatment with clozapine