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UNKNOWNPhase 4NCT02562287

Clozapine Versus Other Atypical Antipsychotics for Bipolar Disorder

The clinical use of clozapine has been an unequivocal advance in the treatment of schizophrenia, a chronic and severe mental illness. A wealth of clinical data demonstrates it offers enhanced efficacy...

Lead sponsor: Hospital de Clinicas de Porto Alegre•1 locations•View source on ClinicalTrials.gov

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Contacts

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

CONTACT

+555191123773 pedromaga2@gmail.com

Sponsors

Lead Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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

Exclusion Criteria

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 2, 2018Terms

Trial snapshot

StatusUNKNOWN

PhasePHASE4

Enrollment54

Start dateOct 2015

Last updatedOct 2, 2018

Condition

Bipolar Disorder

Locations shown

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2018Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions