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Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients (RUBY)

Primary Purpose

Major Depressive Disorder, Treatment Resistant Depression

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Quetiapine XR
Lithium carbonate
SSRI/Venlafaxine
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, MDD, TRD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented clinical diagnosis as confirmed by the M.I.N.I. meeting criteria from the Diagnostic and Statistical Manual of Mental disorders, 4th Edition (DSM-IV) for any of the following:296.2x MDD, Single Episode296.3x MDD, Recurrent Episode
  • Current episode of depression present, at least 42 days prior to enrolment but not more than 18 months
  • MADRS-Score ≥ 25 at enrolment and randomisation

Exclusion Criteria:

  • Patients with a DSM-IV Axis I disorder other than MDD within 6 months of randomisation
  • Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status
  • Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk, or have made a suicide attempt within the past 6 months

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Add-on Quetiapine XR+SSRI/Venlafaxine

Add-on Lithium+SSRI/Venlafaxine

Monotherapy Quetiapine XR

Arm Description

Selective serotonin reuptake inhibitors (SSRI) or Venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od). From previous anti-depressant treatment 64% of the patients had SSRI and 35% had Venlafaxine at baseline.

Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od). From previous anti-depressant treatment 67% of the patients had SSRI and 33% had Venlafaxine at baseline.

Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)

Outcomes

Primary Outcome Measures

Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set)
Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.
Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set)
Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.

Secondary Outcome Measures

Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients
Number of patients in remission, with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure
Number of patients in remission with one previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure
Number of patients in remission with two previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8
Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤8. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12
Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤12. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.
Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients
Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better
Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure
Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better
Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure
Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better
Responder: Clinical Global Impression Improvement (CGI-I) Item 2, All Patients
Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where lower value shows a larger improvement.
Responder: Clinical Global Impression Improvement (CGI)-I Item 2, Patients With One Previous Treatment Failure
Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.
Responder: Clinical Global Impression Improvement (CGI-I) Item 2, Patients With Two Previous Treatment Failure
Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.
Change in Clinical Global Impression Scale (CGI-S), All Patients
Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale form 1-7, where a lower value shows a larger improvement.
Change in Clinical Global Impression Scale (CGI-S), Patients With One Previous Treatment Failure
Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.
Change in Clinical Global Impression Scale (CGI-S), Patients With Two Previous Treatment Failure
Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.
Change in Beck Depression Inventory (BDI)
Self-rating assessment of depressive symptoms using Beck Depression Inventory (BDI). Scale from 0-63, where a lower value shows a larger improvement.
Change in Pain, Measured by Visual Analog Scale (VAS)
Self-rating assessment of pain using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.
Change in Anxiety Measured by Visual Analog Scale (VAS)
Self-rating assessment of anxiety using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.
Change in Anxiety Measured by State-Trait Anxiety Inventory (STAI), State Anxiety Inventory
Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)
Change in Anxiety Measured by STAI, Trait Anxiety Inventory
Self-rating assessment of anxiety measured by State-Trait Anxiety Inventory (STAI), trait anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)
Change in Sleep Quality Measured by Montgomery Asberg Depression Rating Scale (MADRS), Item 4
Sleeping quality measured by Montgomery-Asberg Depression Rating Scale (MADRS) item 4 (reduced sleep) (Scale 0-6, where a lower value shows a larger improvement)
Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)
Self-rated sleeping quality measured by PSQI (Scale 0-21, subscales 0-3, 18 questions, where a lower value shows a larger improvement)
Change in Quality of Life Measured by Short-form Health Survey (SF-36), Mental Component
Self rating assessment of quality in life using SF-36, mental component (Scale 0-100, where a higher value shows a larger improvement)
Change in Quality of Life Measured by Short-form Health Survey (SF-36), Physical Component
Self rating assessment of quality in life using SF-36, physical component (Scale 0-100, where a higher value shows a larger improvement)
Change in Quality of Life Measured by Health Questionnaire EQ-5D as Utility
Self rating assessment of quality in life using EQ-5D utility (Scale 0-100, where a higher value shows a larger improvement)
Change in Work Productivity and Activity Impairment: General Health (WPAI:GH)
Self rating assessment of working productivity using WPAI:GH (Scale 0 to number of hours worked during a week multiplied with the salary in Euro, a lower value shows a larger improvement)
Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, All Patients
The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a 'marked/moderate' therapeutic effect and 'None/Do Not Significantly Interfere' side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm (225, 229 or 221).
Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With One Previous Treatment Failure
The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a 'marked/moderate' therapeutic effect and 'None/Do Not Significantly Interfere' side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.
Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With Two Previous Treatment Failures
The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a 'marked/moderate' therapeutic effect and 'None/Do Not Significantly Interfere' side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.

Full Information

First Posted
November 11, 2008
Last Updated
April 23, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00789854
Brief Title
Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients
Acronym
RUBY
Official Title
A Randomised, 6-week, Multicentre, Open-label, Rater-blinded Parallel Group Study Comparing Quetiapine Extended Release Monotherapy and Augmentation With Lithium Augmentation in Patients With Treatment Resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of the study is to evaluate the efficacy of Quetiapine extended release (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine versus Lithium in combination with an selective serotonin reuptake inhibitor or Venlafaxine versus Quetiapine extended release monotherapy in subjects with treatment resistant depression as assessed by the changes from randomisation to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. As an independent objective, the primary objective will also be evaluated in two subgroups of patients: (1) patients who were resistant to two previous antidepressant therapies and (2) in the subgroup of patients with one previous failure.
Detailed Description
The secondary objectives of the study are to compare the effects of the three different treatment regimen as assessed by the following variables and, if applicable, by their changes from randomisation to week 6 (end of study). Additionally the time of onset of therapeutic effect will be assessed by evaluating efficacy data after the first four days (Day 4) of treatment as well as after the first week of treatment (Day 8). These analyses will also be performed in the subgroups of patients with 2 failed previous antidepressants and patients with 1 failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Treatment Resistant Depression
Keywords
Depression, MDD, TRD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
688 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Add-on Quetiapine XR+SSRI/Venlafaxine
Arm Type
Active Comparator
Arm Description
Selective serotonin reuptake inhibitors (SSRI) or Venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od). From previous anti-depressant treatment 64% of the patients had SSRI and 35% had Venlafaxine at baseline.
Arm Title
Add-on Lithium+SSRI/Venlafaxine
Arm Type
Active Comparator
Arm Description
Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od). From previous anti-depressant treatment 67% of the patients had SSRI and 33% had Venlafaxine at baseline.
Arm Title
Monotherapy Quetiapine XR
Arm Type
Active Comparator
Arm Description
Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
Intervention Type
Drug
Intervention Name(s)
Quetiapine XR
Other Intervention Name(s)
Seroquel XR
Intervention Description
300 mg once daily (od)
Intervention Type
Drug
Intervention Name(s)
Lithium carbonate
Other Intervention Name(s)
Quilonum Retard
Intervention Description
900 mg once daily (od)
Intervention Type
Drug
Intervention Name(s)
SSRI/Venlafaxine
Intervention Description
SSRI - doses within label, Venlafaxine dose up to 225 mg/day
Primary Outcome Measure Information:
Title
Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set)
Description
Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.
Time Frame
6 weeks treatment
Title
Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set)
Description
Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.
Time Frame
6 weeks of treatment
Secondary Outcome Measure Information:
Title
Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients
Description
Number of patients in remission, with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.
Time Frame
6 weeks of treatment
Title
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure
Description
Number of patients in remission with one previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.
Time Frame
6 weeks of treatment
Title
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure
Description
Number of patients in remission with two previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.
Time Frame
6 weeks of treatment
Title
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8
Description
Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤8. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.
Time Frame
6 weeks of treatment
Title
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12
Description
Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤12. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.
Time Frame
6 weeks of treatment
Title
Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients
Description
Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better
Time Frame
6 week of treatments
Title
Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure
Description
Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better
Time Frame
6 weeks of treatment
Title
Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure
Description
Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better
Time Frame
6 weeks of treatment
Title
Responder: Clinical Global Impression Improvement (CGI-I) Item 2, All Patients
Description
Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where lower value shows a larger improvement.
Time Frame
6 weeks of treatment
Title
Responder: Clinical Global Impression Improvement (CGI)-I Item 2, Patients With One Previous Treatment Failure
Description
Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.
Time Frame
6 weeks of treatment
Title
Responder: Clinical Global Impression Improvement (CGI-I) Item 2, Patients With Two Previous Treatment Failure
Description
Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.
Time Frame
6 weeks of treatment
Title
Change in Clinical Global Impression Scale (CGI-S), All Patients
Description
Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale form 1-7, where a lower value shows a larger improvement.
Time Frame
6 weeks of treatment
Title
Change in Clinical Global Impression Scale (CGI-S), Patients With One Previous Treatment Failure
Description
Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.
Time Frame
6 weeks of treatment
Title
Change in Clinical Global Impression Scale (CGI-S), Patients With Two Previous Treatment Failure
Description
Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.
Time Frame
6 weeks of treatment
Title
Change in Beck Depression Inventory (BDI)
Description
Self-rating assessment of depressive symptoms using Beck Depression Inventory (BDI). Scale from 0-63, where a lower value shows a larger improvement.
Time Frame
6 weeks of treatment
Title
Change in Pain, Measured by Visual Analog Scale (VAS)
Description
Self-rating assessment of pain using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.
Time Frame
6 weeks of treatment
Title
Change in Anxiety Measured by Visual Analog Scale (VAS)
Description
Self-rating assessment of anxiety using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.
Time Frame
6 weeks of treatment
Title
Change in Anxiety Measured by State-Trait Anxiety Inventory (STAI), State Anxiety Inventory
Description
Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)
Time Frame
6 weeks of treatment
Title
Change in Anxiety Measured by STAI, Trait Anxiety Inventory
Description
Self-rating assessment of anxiety measured by State-Trait Anxiety Inventory (STAI), trait anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)
Time Frame
6 weeks of treatment
Title
Change in Sleep Quality Measured by Montgomery Asberg Depression Rating Scale (MADRS), Item 4
Description
Sleeping quality measured by Montgomery-Asberg Depression Rating Scale (MADRS) item 4 (reduced sleep) (Scale 0-6, where a lower value shows a larger improvement)
Time Frame
6 weeks of treatment
Title
Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)
Description
Self-rated sleeping quality measured by PSQI (Scale 0-21, subscales 0-3, 18 questions, where a lower value shows a larger improvement)
Time Frame
6 weeks of treatment
Title
Change in Quality of Life Measured by Short-form Health Survey (SF-36), Mental Component
Description
Self rating assessment of quality in life using SF-36, mental component (Scale 0-100, where a higher value shows a larger improvement)
Time Frame
6 weeks of treatment
Title
Change in Quality of Life Measured by Short-form Health Survey (SF-36), Physical Component
Description
Self rating assessment of quality in life using SF-36, physical component (Scale 0-100, where a higher value shows a larger improvement)
Time Frame
6 weeks of treatment
Title
Change in Quality of Life Measured by Health Questionnaire EQ-5D as Utility
Description
Self rating assessment of quality in life using EQ-5D utility (Scale 0-100, where a higher value shows a larger improvement)
Time Frame
6 weeks of treatment
Title
Change in Work Productivity and Activity Impairment: General Health (WPAI:GH)
Description
Self rating assessment of working productivity using WPAI:GH (Scale 0 to number of hours worked during a week multiplied with the salary in Euro, a lower value shows a larger improvement)
Time Frame
6 weeks of treatment
Title
Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, All Patients
Description
The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a 'marked/moderate' therapeutic effect and 'None/Do Not Significantly Interfere' side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm (225, 229 or 221).
Time Frame
6 weeks of treatment
Title
Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With One Previous Treatment Failure
Description
The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a 'marked/moderate' therapeutic effect and 'None/Do Not Significantly Interfere' side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.
Time Frame
6 weeks of treatment
Title
Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With Two Previous Treatment Failures
Description
The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a 'marked/moderate' therapeutic effect and 'None/Do Not Significantly Interfere' side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.
Time Frame
6 week of treatments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented clinical diagnosis as confirmed by the M.I.N.I. meeting criteria from the Diagnostic and Statistical Manual of Mental disorders, 4th Edition (DSM-IV) for any of the following:296.2x MDD, Single Episode296.3x MDD, Recurrent Episode Current episode of depression present, at least 42 days prior to enrolment but not more than 18 months MADRS-Score ≥ 25 at enrolment and randomisation Exclusion Criteria: Patients with a DSM-IV Axis I disorder other than MDD within 6 months of randomisation Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk, or have made a suicide attempt within the past 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bauer, professor
Organizational Affiliation
Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Birgit Ekholm, PhD
Organizational Affiliation
AstraZeneca MC Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Garran
State/Province
Australian Capital Territory
Country
Australia
Facility Name
Research Site
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Everton Park
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Townsville
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Gilberton
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Frankston
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Malvern
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Prahran
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Richmond
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Graz
Country
Austria
Facility Name
Research Site
City
Klagenfurt
Country
Austria
Facility Name
Research Site
City
Salzburg
Country
Austria
Facility Name
Research Site
City
Wels
Country
Austria
Facility Name
Research Site
City
Wiener NEUSTADT
Country
Austria
Facility Name
Research Site
City
Wien
Country
Austria
Facility Name
Research Site
City
Assebroek
Country
Belgium
Facility Name
Research Site
City
Diest
Country
Belgium
Facility Name
Research Site
City
Liege
Country
Belgium
Facility Name
Research Site
City
Tielt
Country
Belgium
Facility Name
Research Site
City
Cerova Koria Village
State/Province
Veliko Tarnovo
Country
Bulgaria
Facility Name
Research Site
City
Kardjali
Country
Bulgaria
Facility Name
Research Site
City
Pazardjik
Country
Bulgaria
Facility Name
Research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Ruse
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Varna
Country
Bulgaria
Facility Name
Research Site
City
Esbjerg N
Country
Denmark
Facility Name
Research Site
City
Frederiksberg
Country
Denmark
Facility Name
Research Site
City
Odense
Country
Denmark
Facility Name
Research Site
City
Aachen
Country
Germany
Facility Name
Research Site
City
Achim
Country
Germany
Facility Name
Research Site
City
Augsburg
Country
Germany
Facility Name
Research Site
City
Bad Homburg
Country
Germany
Facility Name
Research Site
City
Bad Honnef
Country
Germany
Facility Name
Research Site
City
Bad Saarow
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Bielefeld
Country
Germany
Facility Name
Research Site
City
Bochum
Country
Germany
Facility Name
Research Site
City
Butzbach
Country
Germany
Facility Name
Research Site
City
Chemnitz
Country
Germany
Facility Name
Research Site
City
Dresden
Country
Germany
Facility Name
Research Site
City
Duren
Country
Germany
Facility Name
Research Site
City
Dusseldorf
Country
Germany
Facility Name
Research Site
City
Ellwangen
Country
Germany
Facility Name
Research Site
City
Erbach
Country
Germany
Facility Name
Research Site
City
Gelsenkirchen
Country
Germany
Facility Name
Research Site
City
Gutersloh
Country
Germany
Facility Name
Research Site
City
Halle
Country
Germany
Facility Name
Research Site
City
Hattingen
Country
Germany
Facility Name
Research Site
City
Herborn
Country
Germany
Facility Name
Research Site
City
Kassel
Country
Germany
Facility Name
Research Site
City
Kothen
Country
Germany
Facility Name
Research Site
City
Neu-isenburg
Country
Germany
Facility Name
Research Site
City
Neubrandenburg
Country
Germany
Facility Name
Research Site
City
Nurnberg
Country
Germany
Facility Name
Research Site
City
Oldenburg
Country
Germany
Facility Name
Research Site
City
Ostfildern
Country
Germany
Facility Name
Research Site
City
Schwerin
Country
Germany
Facility Name
Research Site
City
Stuttgart
Country
Germany
Facility Name
Research Site
City
Westerstede
Country
Germany
Facility Name
Research Site
City
Wurzburg
Country
Germany
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Gyor
Country
Hungary
Facility Name
Research Site
City
Gyula
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
Country
Hungary
Facility Name
Research Site
City
Bressanone
State/Province
BZ
Country
Italy
Facility Name
Research Site
City
Brunico
State/Province
BZ
Country
Italy
Facility Name
Research Site
City
Cagliari
State/Province
CA
Country
Italy
Facility Name
Research Site
City
Pisa
State/Province
PI
Country
Italy
Facility Name
Research Site
City
Roma
State/Province
RM
Country
Italy
Facility Name
Research Site
City
Bolzano
Country
Italy
Facility Name
Research Site
City
Catania
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Braga
Country
Portugal
Facility Name
Research Site
City
Coimbra
Country
Portugal
Facility Name
Research Site
City
Lisboa
Country
Portugal
Facility Name
Research Site
City
Santarem
Country
Portugal
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Craiova
Country
Romania
Facility Name
Research Site
City
Galati
Country
Romania
Facility Name
Research Site
City
Sibiu
Country
Romania
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Krupina
Country
Slovakia
Facility Name
Research Site
City
Levice
Country
Slovakia
Facility Name
Research Site
City
Liptovsky Mikulas
Country
Slovakia
Facility Name
Research Site
City
Michalovce Stranany
Country
Slovakia
Facility Name
Research Site
City
Presov
Country
Slovakia
Facility Name
Research Site
City
Roznava
Country
Slovakia
Facility Name
Research Site
City
Zilina-bytcica
Country
Slovakia
Facility Name
Research Site
City
Zlate Moravce
Country
Slovakia
Facility Name
Research Site
City
Sama de Langreo
State/Province
Asturias
Country
Spain
Facility Name
Research Site
City
Salamanca
State/Province
Castilla Leon
Country
Spain
Facility Name
Research Site
City
Zamora
State/Province
Castilla Leon
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Vigo
State/Province
Galicia
Country
Spain
Facility Name
Research Site
City
Addlestone
State/Province
Surrey
Country
United Kingdom
Facility Name
Research Site
City
Winnick
State/Province
Warrington
Country
United Kingdom
Facility Name
Research Site
City
Horsham
State/Province
West Sussex
Country
United Kingdom
Facility Name
Research Site
City
Coventry
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Harrow
Country
United Kingdom
Facility Name
Research Site
City
Hull
Country
United Kingdom
Facility Name
Research Site
City
Winsford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23810357
Citation
Bauer M, Dell'osso L, Kasper S, Pitchot W, Dencker Vansvik E, Kohler J, Jorgensen L, Montgomery SA. Extended-release quetiapine fumarate (quetiapine XR) monotherapy and quetiapine XR or lithium as add-on to antidepressants in patients with treatment-resistant major depressive disorder. J Affect Disord. 2013 Oct;151(1):209-19. doi: 10.1016/j.jad.2013.05.079. Epub 2013 Jun 27.
Results Reference
derived

Learn more about this trial

Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients

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