Potentiation of Quetiapine Treatment With Lithium or Aripiprazole in Bipolar 1 Nonresponders Patients
ARIQUELI
ARIQUELI: Potentiation of Quetiapine Treatment in Bipolar 1 Nonresponders Patients With Lithium or Aripiprazole
1 other identifier
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2012
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 28, 2012
CompletedFirst Posted
Study publicly available on registry
October 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedOctober 19, 2012
October 1, 2012
1 year
July 28, 2012
October 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 years
Study Arms (2)
Lithium
EXPERIMENTALPotentiation of previous treatment (Quetiapine monotherapy) with Lithium (0.5 - 0.8 mEq/L)
Aripiprazole
EXPERIMENTALPotentiation of previous treatment (Quetiapine monotherapy) with Aripiprazole (10 - 15 mg)
Interventions
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.
Starting at 10 mg daily, dose will be adjusted up to 15 mg daily according to efficacy and tolerability.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Schizophrenia or schizoaffective disorder
- Mental retardation
- Unstable clinical diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Institute of Psychiatry, University of São Paulo
São Paulo, São Paulo, 05403-010, Brazil
Institute of Psychiatry
São Paulo, São Paulo, 05403010, Brazil
Related Publications (1)
Missio G, Moreno DH, Fernandes F, Bio DS, Soeiro-de-Souza MG, Rodrigues dos Santos D Jr, David DP, Costa LF, Demetrio 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.
PMID: 23805994DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
July 28, 2012
First Posted
October 19, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2015
Last Updated
October 19, 2012
Record last verified: 2012-10