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

Sponsor

University of Sao Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT01710163

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar I Disorder	Drug: Lithium Drug: Aripiprazole	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2013

Anticipated Study Completion Date :

Jun 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Psychiatry, University of São Paulo	São Paulo		Brazil	05403-010
2	Institute of Psychiatry	São Paulo		Brazil	05403010

Sponsors and Collaborators

University of Sao Paulo

Investigators

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