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
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