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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithium | Experimental | Potentiation of previous treatment (Quetiapine monotherapy) with Lithium (0.5 - 0.8 mEq/L) |
|
| Aripiprazole | Experimental | Potentiation of previous treatment (Quetiapine monotherapy) with Aripiprazole (10 - 15 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovani Missio | Contact | + 55 11 2661 6648 | gmissio@mac.com | |
| Ricardo Alberto Moreno, MD, PhD | Contact | + 55 11 2661 6648 | rmoreno@sti.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Ricardo Alberto Moreno, MD, PhD | Institute of Psychiatry, University of São Paulo | Principal Investigator |
| Giovani Missio, MD | Institute of Psychiatry, University of São Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Psychiatry, University of São Paulo | Recruiting | São Paulo | São Paulo | 05403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23805994 | Derived | 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. |
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| ID | Term |
|---|---|
| D008094 | Lithium |
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| Aripiprazole | Drug | Starting at 10 mg daily, dose will be adjusted up to 15 mg daily according to efficacy and tolerability. |
|
| Institute of Psychiatry | Recruiting | São Paulo | São Paulo | 05403010 | Brazil |
|
| D008670 |
| Metals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |