Bipolar I Disorder
Conditions
Keywords
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
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.
Interventions
DRUGLithium
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.
DRUGAripiprazole
Starting at 10 mg daily, dose will be adjusted up to 15 mg daily according to efficacy and tolerability.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
Brazil
Contacts
Primary ContactGiovani Missio
Backup ContactRicardo Alberto Moreno, MD, PhD
Outcome results
None listed