The Quietude Study: Quetiapine Use for Agitated Depression

NCT01363310 | Terminated Phase 3

• 1 other identifier: D1443C00037
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 11

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline to endpoint in the Hamilton Depression Rating Scale 17-Item (HAMD-17) total score

  A tool to assess the range of symptoms of depression

  Day 1, Day 57

Secondary Outcomes (14)

• Change in anxiety factor score on the Hamilton Depression Rating Scale 17-item (HAMD-17) from baseline to endpoint

  Day 1, Day 57

• Change from baseline to endpoint in Hamilton Anxiety Rating Scale (HAMA) total score

  Day 1, Day 57

• Change in Clinical Global Impression score from baseline to endpoint

  Screening Visit, Day 1, Day 8, Day 15, Day 29, Day 43, Day 57

• Change from baseline to endpoint in Sheehan Disability Scale (SDS) sub-scales and total score

  Day 1, Day 57

• Change in Hamilton Depression Rating Scale 17-item (HAMD-17) sleep disturbance factor score on the from baseline to endpoint

  Day 1, Day 57

Study Arms (2)

Quetiapine XR

ACTIVE COMPARATOR

Drug: Quetiapine XR

Escitalopram

ACTIVE COMPARATOR

Drug: Escitalopram

Interventions

Quetiapine XR DRUG

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

Also known as: Seroquel XR

Quetiapine XR

Escitalopram DRUG

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

Escitalopram

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Physicians Research And Education Network: lead

Study Sites (11)

Aggarwal and Associates Ltd

Brampton, Ontario, L6T 0G1, Canada

Location

Aptekar Medicine Professional Corporation

Brampton, Ontario, L6W 2A4, Canada

Location

Chatham-Kent Health Alliance

Chatham, Ontario, N7L 1B7, Canada

Location

Fort Erie Group Family Practice

Fort Erie, Ontario, L2A 1Z3, Canada

Location

Brady Clinic

Greater Sudbury, Ontario, P3E 1H5, Canada

Location

Georgina Family Medical Centre

Keswick, Ontario, L4P 2C7, Canada

Location

Richmond Oxford Walk-In Clinic

London, Ontario, N6A 5G6, Canada

Location

Gerald Rockman Medicine Professional Corporation

Scarborough Village, Ontario, M1N 1W8, Canada

Location

Bloor-Park Medical Centre

Toronto, Ontario, M6G 1L4, Canada

Location

Primary Care Lung

Toronto, Ontario, M6H 3M2, Canada

Location

Manna Research

Toronto, Ontario, M9W 4L6, Canada

Location

MeSH Terms

Interventions

Escitalopram

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Roger McIntyre, MD, FRCPC

  Physicians Research And Education Network

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: June 1, 2011
• Study Start: October 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: January 8, 2014

Record last verified: 2014-01

Locations

CA (11)