The Quietude Study: Quetiapine Use for Agitated Depression

This is an interventional treatment trial for Depression With Prominent Agitation Read More

Inclusion Criteria:

• Male or female
• Age 18 to 65
• Outpatient at enrolment
• A diagnosis of major depressive disorder
• Baseline HAMD-17 score > 20 and HAMD Item1 score > 2 both at enrolment and baseline
• Significant agitation
• CGI-S score > 4 at screening and baseline
• Negative serum pregnancy test at enrolment and use of a reliable method of birth control during the study
• Able to understand and comply with the requirements of the study
• Able and willing to give meaningful informed written consent

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