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

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ClinicalTrials.gov Identifier: NCT01710163
Recruitment Status : Unknown
Verified October 2012 by Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : October 19, 2012
Last Update Posted : October 19, 2012
Sponsor:
Information provided by (Responsible Party):
Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE July 28, 2012
First Posted Date  ICMJE October 19, 2012
Last Update Posted Date October 19, 2012
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Potentiation of Quetiapine Treatment With Lithium or Aripiprazole in Bipolar 1 Nonresponders Patients
Official Title  ICMJE ARIQUELI: Potentiation of Quetiapine Treatment in Bipolar 1 Nonresponders Patients With Lithium or Aripiprazole
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bipolar I Disorder
Intervention  ICMJE
  • 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.
  • Drug: Aripiprazole
    Starting at 10 mg daily, dose will be adjusted up to 15 mg daily according to efficacy and tolerability.
Study Arms  ICMJE
  • Experimental: Lithium
    Potentiation of previous treatment (Quetiapine monotherapy) with Lithium (0.5 - 0.8 mEq/L)
    Intervention: Drug: Lithium
  • Experimental: Aripiprazole
    Potentiation of previous treatment (Quetiapine monotherapy) with Aripiprazole (10 - 15 mg)
    Intervention: Drug: Aripiprazole
Publications * Missio G, Moreno DH, Fernandes F, Bio DS, Soeiro-de-Souza MG, Rodrigues dos Santos D Jr, David DP, Costa LF, Demétrio FN, Moreno RA. The ARIQUELI study: potentiation of quetiapine in bipolar I nonresponders with lithium versus aripiprazole. Trials. 2013 Jun 27;14:190. doi: 10.1186/1745-6215-14-190.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 16, 2012)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01710163
Other Study ID Numbers  ICMJE ARIQUELI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ricardo Alberto Moreno, MD, PhD Institute of Psychiatry, University of São Paulo
Study Chair: Giovani Missio, MD Institute of Psychiatry, University of São Paulo
PRS Account University of Sao Paulo
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP