The Quietude Study: Quetiapine Use for Agitated Depression

Exclusion Criteria

• •Another Axis I diagnosis of primary focus within 6 months of enrolment
• •Axis II disorder causing impact on current diagnosis
• •Current depressive episode \<4 weeks, or \>12 months
• •Substance or alcohol abuse or dependency as defined by DSM IV within 6 months of enrolment
• •Any pervasive developmental disorder or dementing disorder
• •Treatment with other antipsychotics, mood stabilizer or other psychoactive drugs less than 7 days prior to randomization
• •Treatment with fluoxetine less than 28 days prior to baseline
• •Treatment with MAO inhibitors, anxiolytic drugs in excess of 2 mg lorazepam equivalents/day.
• •Insufficient response to more than two antidepressants during the index episode prior to study involvement
• •Known lack of antidepressant response to quetiapine at a dose of at least 50 mg/day x 4 weeks
• •Known lack of antidepressant response to escitalopram at a dose of at least 10 mg/day
• •Known intolerance or hypersensitivity to quetiapine or escitalopram
• •Treatment with Electroconvulsive therapy within 90 days prior to baseline
• •Use of Potent P450 3A4 inhibitors or inducers within 14 days of baseline
• •AST \& ALT ≥ 3X ULN
• •TSH ≥ 10% ULN
• •Unstable medical condition
• •Medical condition the would affect absorption, distribution, metabolism or excretion of study treatment
• •Significant ECG abnormalities
• •Pregnancy or lactation
• •Patients with increased suicidal risks, HAM-D item 3 ≥3 or have made a suicide attempt within the past 6 months.
• •Patients who, in the investigators opinion, will require psychotherapy (other than supportive psychotherapy) during the study period, unless psychotherapy has been ongoing for a minimum of 3 months prior to randomisation
• •A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
• •Unstable DM defined as enrolment glycosylated haemoglobin (HbA1c) \>8.5%.
• •Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
• •Not under physician care for DM.
• •Physician responsible for patient's DM care has not indicated that patient's DM is controlled.
• •Physician responsible for patient's DM care has not approved patient's participation in the study
• •Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 weeks.
• •Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study
• •Clinically significant deviation from the reference range in clinical laboratory test results
• •An absolute neutrophil count (ANC) of 1.5 x 109 per liter
• •Those who are involved in the planning and/or conduct of the study cannot be enrolled as subjects
• •Previous enrolment or randomization in the present study
• •Participation in another medication trial within 4 weeks prior to enrolment into the study herein