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Potentiation of Quetiapine Treatment With Lithium or Aripiprazole in Bipolar 1 Nonresponders Patients

Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar I Disorder

Intervention: Lithium (Drug); Aripiprazole (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Sao Paulo

Official(s) and/or principal investigator(s):
Ricardo Alberto Moreno, MD, PhD, Principal Investigator, Affiliation: Institute of Psychiatry, University of São Paulo
Giovani Missio, MD, Study Chair, Affiliation: Institute of Psychiatry, University of São Paulo

Overall contact:
Giovani Missio, Phone: + 55 11 2661 6648, Email: gmissio@mac.com

Summary

The purpose of this study is to determine whether Bipolar I Disorder refractory treatment with Quetiapine monotherapy could be better potentiated with Lithium or Aripiprazole. The investigators hypothesized that Lithium or Aripiprazole would provide similar compliance and tolerability in maintenance treatment.

Clinical Details

Official title: ARIQUELI: Potentiation of Quetiapine Treatment in Bipolar 1 Nonresponders Patients With Lithium or Aripiprazole

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical diagnosis of Bipolar Disorder, type I, in current episode (manic/hypomanic,

mixed or depression)

- The patient or his (her) legal representative should understand the nature of the

study and sign the Informed Consent Exclusion Criteria:

- Schizophrenia or schizoaffective disorder

- Mental retardation

- Unstable clinical diseases

Locations and Contacts

Giovani Missio, Phone: + 55 11 2661 6648, Email: gmissio@mac.com

Institute of Psychiatry, São Paulo 05403010, Brazil; Recruiting
Missio

Institute of Psychiatry, University of São Paulo, São Paulo 05403-010, Brazil; Recruiting
Giovani Missio, Phone: +55 11 26616648, Email: gmissio@mac.com
Ricardo Alberto Moreno, MD, PhD, Phone: +55 11 26616648, Email: rmoreno@sti.com.br

Additional Information

Starting date: June 2012
Last updated: October 16, 2012

Page last updated: August 23, 2015

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