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

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ClinicalTrials.gov Identifier: NCT01710163
Recruitment Status : Unknown
Verified October 2012 by Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : October 19, 2012
Last Update Posted : October 19, 2012
Sponsor:
Information provided by (Responsible Party):
Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01710163


Contacts
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Contact: Giovani Missio + 55 11 2661 6648 gmissio@mac.com
Contact: Ricardo Alberto Moreno, MD, PhD + 55 11 2661 6648 rmoreno@sti.com.br

Locations
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Brazil
Institute of Psychiatry, University of São Paulo Recruiting
São Paulo, Brazil, 05403-010
Contact: Giovani Missio    +55 11 26616648    gmissio@mac.com   
Contact: Ricardo Alberto Moreno, MD, PhD    +55 11 26616648    rmoreno@sti.com.br   
Institute of Psychiatry Recruiting
São Paulo, Brazil, 05403010
Contact: Missio         
Sponsors and Collaborators
University of Sao Paulo
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ricardo Alberto Moreno, M.D., Ph.D., MD PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01710163    
Other Study ID Numbers: ARIQUELI
First Posted: October 19, 2012    Key Record Dates
Last Update Posted: October 19, 2012
Last Verified: October 2012
Keywords provided by Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo:
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
Additional relevant MeSH terms:
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Aripiprazole
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists