The Quietude Study: Quetiapine Use for Agitated Depression

NCT ID: NCT01363310

Last Updated: 2014-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-02-28

Brief Summary

Most individuals with major depressive disorder manifest clinically significant agitation. Concurrent agitation in a depressed individual is associated with an intensification of mood symptoms, decreased probability of recovery, increased recurrence risk, suicidality, and increased medical-service utilization. The occurrence of anxiety/agitation phenomenology in the depressed patient often invites the need for augmentation strategies (e.g. atypical antipsychotics, benzodiazepines, etc.) and complicated polypharmacy regimens. Moreover, individuals with major depressive disorder often report worsening of symptom severity, irritability, hostility, dysphoria, and significant subjective distress (This response pattern is similar to individuals with bipolar disorder).

Results from large research studies provide evidence indicating that quetiapine is capable of offering clinically significant multidimensional symptom relief in bipolar depression. Moreover, results from several trials in major depressive disorder and generalized anxiety disorder have established the efficacy of quetiapine therapy for unipolar depression and anxiety syndromes. So far, no atypical antipsychotic agent has been evaluated specifically for the treatment of agitated depression.

In this study, it is hypothesized that persons with major depressive disorder and prominent agitation (i.e. agitated depression) will exhibit a more favourable response and tolerability profile to quetiapine XR when compared to escitalopram.

Conditions

Depression With Prominent Agitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Quetiapine XR

Group Type: ACTIVE_COMPARATOR

Quetiapine XR

Intervention Type: DRUG

Dosage form: tablets Day 1-2: 50 mg Day 3-7: 150 mg Day 8-57: either 150 or 300 mg/day (flexible)

Escitalopram

Group Type: ACTIVE_COMPARATOR

Escitalopram

Intervention Type: DRUG

Dosage form: capsules Day 1-7: 10 mg Day 8-57: 10 or 20 mg/day (flexible)

Interventions

Quetiapine XR

Dosage form: tablets Day 1-2: 50 mg Day 3-7: 150 mg Day 8-57: either 150 or 300 mg/day (flexible)

Intervention Type: DRUG

Escitalopram

Dosage form: capsules Day 1-7: 10 mg Day 8-57: 10 or 20 mg/day (flexible)

Intervention Type: DRUG

Other Intervention Names

Seroquel XR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Physicians Research And Education Network

OTHER

Sponsor Role: lead

Responsible Party

Physicians' Research and Education Network

Principal Investigators

Roger McIntyre, MD, FRCPC

Role: STUDY_DIRECTOR

Physicians Research And Education Network

Locations

Aggarwal and Associates Ltd

Brampton, Ontario, Canada

Aptekar Medicine Professional Corporation

Brampton, Ontario, Canada

Chatham-Kent Health Alliance

Chatham, Ontario, Canada

Fort Erie Group Family Practice

Fort Erie, Ontario, Canada

Brady Clinic

Greater Sudbury, Ontario, Canada

Georgina Family Medical Centre

Keswick, Ontario, Canada

Richmond Oxford Walk-In Clinic

London, Ontario, Canada

Gerald Rockman Medicine Professional Corporation

Scarborough Village, Ontario, Canada

Bloor-Park Medical Centre

Toronto, Ontario, Canada

Primary Care Lung

Toronto, Ontario, Canada

Manna Research

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

D1443C00037

Identifier Type: -

Identifier Source: org_study_id