None listed
Conditions
Interventions
Group 1 Type of group
Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Group name:Group 2 Type of group
Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg + Lithium carbonate twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day
Sponsors
ASTRAZENECA - PERU,
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • Provision of written informed consent before the start of any procedure related to the study. Patients who are deemed unable to provide informed consent may be enrolled if written informed consent has been obtained from the Legally Authorized Representative of the patient. • Male and female patients between 18 and 65 years of age, inclusive. • Meet the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV, American Psychiatric Association 1994) for bipolar disorder I or II, most recent episode of depression (296.5x 296.89x), confirmed by the amended version (by Dr. Michael First) of the Structured Clinical Interview for the DSM-IV (SCID). The duration of the current major episode must be less than one year, but longer than 2 weeks. • Hospitalized patients will be enrolled in the study, but the investigator may decide to hospitalize the patient during the washing period. • Total HAM-D score (17-item)> 20. • HAM-D score item 1 (depressed affect)> 2. • Total YMRS <12 • Patients with conception potential must present a negative urine pregnancy test at the time of enrollment and must use a reliable method of birth control, eg, barrier method, oral contraceptive, implant, dermal contraception, injectable contraceptive Long-term intrauterine device, or tubal ligation during the study. • Be able to understand and comply with the requirements of the study, in the opinion of the researcher.
Exclusion criteria
Exclusion criteria: • Patients with a current DSM-IV Axis 1 disorder other than bipolar disorder within the first 6 months of enrollment. • History of lack of response to adequate treatment (6 weeks) or more, of 2 classes of antidepressants during your current episode. • Patients with prior treatment with quetiapine or lithium will be excluded. The patient should be enrolled if treatment with these medications is at sub therapeutic levels (serum lithium concentration 12 months) and except dependence on caffeine or nicotine) defined by the DSM-IV criteria. Patients with a positive urine toxicological screening will be excluded only if they meet the DSM-IV criteria for abuse or dependence. However, a single urine drug screening for cocaine, heroin or PCP will lead to exclusion. • Use of drugs that induce or inhibit the enzymes of the hepatic metabolizing cytochrome P450 3A4 within 14 days prior to randomization eg, inducers: phenytoin, carbamazepine, barbiturates, rifampin, rifabutin, glucocorticoids, thioridazine and St John´s Wort and inhibitors : ketoconazole (except for topical use), itraconazole, fluconazole, erythromycin, clarithromycin, fluvoxamine, nefazodone, troleandomycin, indinavir, nelfinavir, ritonavir, and saquinavir). • Electroconvulsive therapy (ECT) within 28 days prior to randomization. • Patients who do not have the ability to discontinue all psychoactive medications (excluding benzodiazepines), including antidepressants, antipsychotics and affect stabilizers at least 7 days before randomization and consistent with the pharmacokinetics of the medication • Patients who, according to the opinion of the researchers, require the start of psychotherapy during the study period. Note: psychotherapy for a minimum of 3 months can continue. • Patients who, in the opinion of the investigator, present a serious current suicide risk or homicidal risk in Visit 1 (HAM-D item 3 score of 3 or greater), or who have presented a suicide attempt within the previous 6 months. • Patients with a history of significant cardiac, renal, neurological, cerebrovascular, metabolic or pulmonary disease, congestive heart failure or other disease or clinical finding that is unstable or that, in the opinion of the researcher, is negatively affected by the study medication or that may affect the study medication. • Patients who have suffered myocardial infarction 1 year before the visit 1. • Patients with clinically significant abnormal laboratory findings at visit 2. • Patients with an absolute neutrophil count (ANC) of 1.5 mg / dL) or hepatic impairment (ALT or AST 3 times higher than the normal limit). • Patients whose TSH is> 10% above the normal upper limit. Patients maintained with thyroid medication should be euthyroid for a period of at least 3 months before Visit 1. • Patients with clinically significant abnormalities in the ECG. • Risk of transmission of the human immunodeficiency virus (HIV) hepatitis B, C, through blood or other body fluids, according to the investigator. • A patient with Diabetes Mellitus (DM) who meets one of the following criteria: Unstable DM defined as HbAIc (or HgA1c)> 8.5% at the time of enrollment, Hospitalized for DM treatment o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The change of MADRS Total Score from baseline to the end of treatment was calculated by subtracting the MADRS Total Score assessed at week 8 from the baseline one (Baseline - 8 weeks). The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms. Measure:Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Timepoints:Baseline, 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Response rate defined as the percentage of patients with a ≥50% reduction from baseline in the MADRS total score to the final assessment at week 8. The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms. Measure:Response Rate for MADRS Timepoints:Baseline, 8 weeks ; Outcome name:The mean change of HAM-D Total Score from baseline to the end of treatment was calculated by subtracting the HAM-D Total Score assessed at week 8 from the baseline one (Baseline - week 8). HAM-D is a multiple choice questionnaire used to rate the severity of a patients major depression. It consists of 17 different items with possible scores from 0 to 4 or 0 to 2 or 0 to 6 depending on the items. Sum the total of all seventeen items gives the HAM-D Total Score, which may range from 0 (min) to 53 (max). The higher the score, the more severe the depression. Measure:Hamilton Rating Scale for Depression (HAM-D) Total Score Timepoints:Baseline, 8 weeks ; Outcome name:The reported mean change in the CGI-S score was calculated as baseline - week 8. CGI-S is a 7-point scale that requires the clinician to rate the severity of the patients illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Measure:Change in the Clinical Global Impression Severity (CGI-S) Score. Timepoints:Baseline, 8 weeks ; Outcome name:The mean change in HAM-A total score from baseline to final assessment was calculated by subtracting the HAM-A Total score assessed at week 8 from the total score assessed at the baseline (baseline - week 8). The | — |
Countries
Argentina, Brazil, Chile, Colombia, Guatemala, Mexico, Peru, Turkey, Venezuela
Contacts
Public ContactJose Fermin Lavado
ASTRAZENECA PERU S.A.
Outcome results
None listed