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

University of Sao Paulo

Status and phase: Unknown; Phase 4

Conditions: Bipolar I Disorder

Treatments: Drug: Aripiprazole; Drug: Lithium

Study type: Interventional

Funder types: Other

Identifiers

NCT01710163

ARIQUELI

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Lithium

Experimental group

Description:

Potentiation of previous treatment (Quetiapine monotherapy) with Lithium (0.5 - 0.8 mEq/L)

Treatment:

Drug: Lithium

Aripiprazole

Experimental group

Description:

Potentiation of previous treatment (Quetiapine monotherapy) with Aripiprazole (10 - 15 mg)

Treatment:

Drug: Aripiprazole