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

October 16, 2012 updated by: Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-010
        • Recruiting
        • Institute of Psychiatry, University of Sao Paulo
        • Contact:
        • Contact:
      • São Paulo, Brazil, 05403010
        • Recruiting
        • Institute of Psychiatry
        • Contact:
          • Missio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lithium
Potentiation of previous treatment (Quetiapine monotherapy) with Lithium (0.5 - 0.8 mEq/L)
Drug: Lithium
Starting at 300 mg daily, weekly dose will be adjusted according to blood serum level (between 0.5 -0.8mEq/l) according to efficacy and tolerability.
Experimental: Aripiprazole
Potentiation of previous treatment (Quetiapine monotherapy) with Aripiprazole (10 - 15 mg)
Drug: Aripiprazole
Starting at 10 mg daily, dose will be adjusted up to 15 mg daily according to efficacy and tolerability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Ricardo Alberto Moreno, MD, PhD, Institute of Psychiatry, University of Sao Paulo
  • Study Chair: Giovani Missio, MD, Institute of Psychiatry, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

July 28, 2012

First Submitted That Met QC Criteria

October 16, 2012

First Posted (Estimate)

October 19, 2012

Study Record Updates

Last Update Posted (Estimate)

October 19, 2012

Last Update Submitted That Met QC Criteria

October 16, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARIQUELI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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