Potentiation of Quetiapine Treatment With Lithium or Aripiprazole in Bipolar 1 Nonresponders Patients
- Registration Number
- NCT01710163
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lithium Lithium Potentiation of previous treatment (Quetiapine monotherapy) with Lithium (0.5 - 0.8 mEq/L) Aripiprazole Aripiprazole Potentiation of previous treatment (Quetiapine monotherapy) with Aripiprazole (10 - 15 mg)
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Institute of Psychiatry, University of São Paulo
🇧🇷São Paulo, Brazil
Institute of Psychiatry
🇧🇷São Paulo, Brazil