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

NCT ID: NCT01710163

Last Updated: 2012-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Bipolar I Disorder

Keywords

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Lithium Carbonate Lithium Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Sensory System Agents Antipsychotic Agents Antidepressive Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lithium

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

Group Type EXPERIMENTAL

Lithium

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Aripiprazole

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Ricardo Alberto Moreno, M.D., Ph.D.

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ricardo Alberto Moreno, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Psychiatry, University of São Paulo

Giovani Missio, MD

Role: STUDY_CHAIR

Institute of Psychiatry, University of São Paulo

Locations

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Institute of Psychiatry, University of São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Institute of Psychiatry

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Giovani Missio

Role: CONTACT

Phone: + 55 11 2661 6648

Email: [email protected]

Ricardo Alberto Moreno, MD, PhD

Role: CONTACT

Phone: + 55 11 2661 6648

Email: [email protected]

Facility Contacts

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Giovani Missio

Role: primary

Ricardo Alberto Moreno, MD, PhD

Role: backup

Missio

Role: primary

References

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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.

Reference Type DERIVED
PMID: 23805994 (View on PubMed)

Other Identifiers

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ARIQUELI

Identifier Type: -

Identifier Source: org_study_id