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

Bipolar I Disorder Clinical Trial

— ARIQUELI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01710163
• Other study ID #: ARIQUELI
• Status: Recruiting
• Phase: Phase 4
• First received: July 28, 2012
• Last updated: October 16, 2012
• Start date: June 2012
• Est. completion date: June 2015

Study information

• Verified date: October 2012
• Source: University of Sao Paulo
• Contact: Giovani Missio
• Phone: + 55 11 2661 6648
• Email: gmissio[@]mac.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bipolar I Disorder

Intervention

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.
• Aripiprazole
Starting at 10 mg daily, dose will be adjusted up to 15 mg daily according to efficacy and tolerability.

Locations

Country	Name	City	State
Brazil	Institute of Psychiatry	São Paulo
Brazil	Institute of Psychiatry, University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No