None listed
Conditions
Interventions
Group 1 Type of group
After receiving Quetiapine for 20 weeks at a dose of 300-800 mg / day, according to the severity of the disease, patients selected for this group will continue to receive quetiapine at a dose of 300-800 mg / d, which may be titled according to medical criteria
Group name:Group 3 Type of group
After receiving Quetiapine for 20 weeks at a dose of 300-800 mg / day, according to the severity of the disease, the patients selected for this group will start with tablets with placebo q/24 hours the 104th week.
Sponsors
ASTRAZENECA - PERU,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Provide written informed consent before initiating any procedure 2) A diagnosis of Bipolar I Disorder, Most Recent Manic Episode, Bipolar I Disorder, Most Recent Depressive Episode or Bipolar I Disorder, Most Recent Mixed Episode, with or without psychotic features 3) Male or female> 18 years of age. 4) At least 1 manic, depressive or mixed episode in the previous 2 years 5) One of the following: a) A current manic, depressive or mixed episode, according to the DSM-IV criteria b) A manic, depressive or mixed episode in the previous 26 weeks 6) Women of childbearing age should be using a reliable method of contraception. 7) Able to understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1) Diagnosis of anxiety disorder. 2) Known intolerance or lack of response to quetiapine or lithium fumarate. 3) Pregnancy or lactation: women of childbearing age must have a negative test for human chorionic gonadotrophin (HCG) in serum. 4) Substance or alcohol dependence. 5) Abuse of opiates, amphetamine, barbiturates, cocaine, cannabinoids or hallucinogens. 6) Use of any of the cytochrome P450 3A4 inhibitors in the 14 days prior to enrollment. 7) Use of any of the inducers of cytochrome P450 3A4 in the 14 days prior to enrollment. 8) Concentration of thyroid stimulating hormone (TSH) greater than 10% above the upper limit 9) Unstable or inadequately treated medical disease 10) Patient with unstable Diabetes Mellitus (DM), untreated or with other conditions that prevent him from participating in the study 11) Medical conditions that would affect the absorption, distribution, metabolism or excretion of the treatment 12) Use of an experimental drug within 30 days prior to enrollment. 13) Patient previously enrolled in this study, study D1447C00126 or study D1447C00127. 14) Patient who participates in the programming and conduction of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: Recurrence will be confirmed by at least 1 of the following criteria: 1) Start of an antipsychotic, antidepressant, mood stabilizer other than the assigned mood stabilizer, anxiolytic other than lorazepam or any other medication to treat a manic, depressive event or mixed. 2) Hospitalization due to a manic, depressive or mixed event. 3) Young mania classification scale (YMRS)> 20 in 2 consecutive evaluations or in the final evaluation. 4) Discontinuation of a study patient if, according to the investigator s criteria, the discontinuation was due to a manic, depressive or mixed event. Measure:Recurrence time of an affective episode. Timepoints:Open phase, weeks: 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24. Randomized phase, weeks: 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 68, 76, 84, 92, 104. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: The recurrence of a manic event will be defined as: 1) Start of an antipsychotic, stabilizer of the mood, anxiolytic other than lorazepam or any other medication to treat a manic or mixed event, with predominance of manic symptoms. 2) Hospitalization due to a manic event or mixed event with predominance of manic symptoms. 3) Score ≥ 20 on the Young Mania Rating Scale (YMRS) on 2 consecutive evaluations or score ≥ 20 on the final evaluation if the patient discontinues. 4) Discontinuation of a study patient if the discontinuation was due to a manic or mixed event with predominance of manic symptoms. Measure:Time until the recurrence of a manic event. Timepoints:Open phase, weeks: 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24. Randomized phase, weeks: 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 68, 76, 84, 92, 104. ; Outcome name:Clinical evaluation: The recurrence of a depressive event is defined as: 1) Start of an antidepressant, stabilizer of the mood, anxiolytic other than lorazepam or any other medication to treat a depressive or mixed event, with predominance of depressive symptoms. 2) Hospitalization due to a depressive event or mixed event with a predominance of depressive symptoms. 3) Score ≥ 20 on the Montgomery-Asberg Depression Rating Scale (MADRS) on 2 consecutive evaluations or score ≥ 20 on the MADRS in the final evaluation if the patient discontinues. 4) Discontinuation of a study patient if the discontinuation was due to a depressive or mixed event with a predominance of depressive symptoms. Measure:Recurrence time of a depressive event. Timepoints: Open phase, weeks: 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, Randomized phase, weeks: 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 68, 76, 84, 92, 104 ; Outcome name:Young mania classification scale (YMRS), Montgomery-Asberg Depression Rating Scale (MADRS) and Global Clinical Impression | — |
Countries
Argentina, Bulgaria, Colombia, India, Lithuania, Malasya, Mexico, Peru, Philippines, Romania, Russian Federation, Taiwan, Ukraine, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed