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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00789854
Other study ID # D1443L00044
Secondary ID
Status Completed
Phase Phase 3
First received November 11, 2008
Last updated April 23, 2012
Start date November 2008
Est. completion date August 2009

Study information

Verified date April 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Australia: National Health and Medical Research CouncilAustria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicinal Products and Health ProductsBulgaria: Bulgarian Drug AgencyDenmark: Danish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyItaly: The Italian Medicines AgencyPortugal: National Pharmacy and Medicines InstituteRomania: National Medicines InstituteSlovakia: State Institute for Drug ControlSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 688
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Quetiapine XR
300 mg once daily (od)
Lithium carbonate
900 mg once daily (od)
SSRI/Venlafaxine
SSRI - doses within label, Venlafaxine dose up to 225 mg/day

Locations

Country Name City State
Australia Research Site Brisbane Queensland
Australia Research Site Clayton Victoria
Australia Research Site Everton Park Queensland
Australia Research Site Frankston Victoria
Australia Research Site Garran Australian Capital Territory
Australia Research Site Gilberton South Australia
Australia Research Site Heidelberg Victoria
Australia Research Site Malvern Victoria
Australia Research Site Prahran Victoria
Australia Research Site Richmond Victoria
Australia Research Site Townsville Queensland
Austria Research Site Graz
Austria Research Site Klagenfurt
Austria Research Site Salzburg
Austria Research Site Wels
Austria Research Site Wien
Austria Research Site Wiener NEUSTADT
Belgium Research Site Assebroek
Belgium Research Site Diest
Belgium Research Site Liege
Belgium Research Site Tielt
Bulgaria Research Site Cerova Koria Village Veliko Tarnovo
Bulgaria Research Site Kardjali
Bulgaria Research Site Pazardjik
Bulgaria Research Site Pleven
Bulgaria Research Site Ruse
Bulgaria Research Site Sofia
Bulgaria Research Site Varna
Denmark Research Site Esbjerg N
Denmark Research Site Frederiksberg
Denmark Research Site Odense
Germany Research Site Aachen
Germany Research Site Achim
Germany Research Site Augsburg
Germany Research Site Bad Homburg
Germany Research Site Bad Honnef
Germany Research Site Bad Saarow
Germany Research Site Berlin
Germany Research Site Bielefeld
Germany Research Site Bochum
Germany Research Site Butzbach
Germany Research Site Chemnitz
Germany Research Site Dresden
Germany Research Site Duren
Germany Research Site Dusseldorf
Germany Research Site Ellwangen
Germany Research Site Erbach
Germany Research Site Gelsenkirchen
Germany Research Site Gutersloh
Germany Research Site Halle
Germany Research Site Hattingen
Germany Research Site Herborn
Germany Research Site Kassel
Germany Research Site Kothen
Germany Research Site Neu-isenburg
Germany Research Site Neubrandenburg
Germany Research Site Nurnberg
Germany Research Site Oldenburg
Germany Research Site Ostfildern
Germany Research Site Schwerin
Germany Research Site Stuttgart
Germany Research Site Westerstede
Germany Research Site Wurzburg
Hungary Research Site Budapest
Hungary Research Site Gyor
Hungary Research Site Gyula
Hungary Research Site Nyiregyhaza
Italy Research Site Bolzano
Italy Research Site Bressanone BZ
Italy Research Site Brunico BZ
Italy Research Site Cagliari CA
Italy Research Site Catania
Italy Research Site Napoli
Italy Research Site Pisa PI
Italy Research Site Roma RM
Italy Research Site Roma
Portugal Research Site Braga
Portugal Research Site Coimbra
Portugal Research Site Lisboa
Portugal Research Site Santarem
Romania Research Site Bucharest
Romania Research Site Craiova
Romania Research Site Galati
Romania Research Site Sibiu
Slovakia Research Site Bratislava
Slovakia Research Site Krupina
Slovakia Research Site Levice
Slovakia Research Site Liptovsky Mikulas
Slovakia Research Site Michalovce Stranany
Slovakia Research Site Presov
Slovakia Research Site Roznava
Slovakia Research Site Zilina-bytcica
Slovakia Research Site Zlate Moravce
Spain Research Site Barcelona Cataluna
Spain Research Site Salamanca Castilla Leon
Spain Research Site Sama de Langreo Asturias
Spain Research Site Vigo Galicia
Spain Research Site Zamora Castilla Leon
United Kingdom Research Site Addlestone Surrey
United Kingdom Research Site Coventry
United Kingdom Research Site Glasgow
United Kingdom Research Site Harrow
United Kingdom Research Site Horsham West Sussex
United Kingdom Research Site Hull
United Kingdom Research Site Winnick Warrington
United Kingdom Research Site Winsford

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Bulgaria,  Denmark,  Germany,  Hungary,  Italy,  Portugal,  Romania,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 weeks treatment No
Primary 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. 6 weeks of treatment No
Secondary 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. 6 weeks of treatment No
Secondary 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. 6 weeks of treatment No
Secondary 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. 6 weeks of treatment No
Secondary 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. 6 weeks of treatment No
Secondary 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. 6 weeks of treatment No
Secondary 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 6 week of treatments No
Secondary 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 6 weeks of treatment No
Secondary 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 6 weeks of treatment No
Secondary 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. 6 weeks of treatment No
Secondary 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. 6 weeks of treatment No
Secondary 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. 6 weeks of treatment No
Secondary 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. 6 weeks of treatment No
Secondary 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. 6 weeks of treatment No
Secondary 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. 6 weeks of treatment No
Secondary 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. 6 weeks of treatment No
Secondary 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. 6 weeks of treatment No
Secondary 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. 6 weeks of treatment No
Secondary 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) 6 weeks of treatment No
Secondary 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) 6 weeks of treatment No
Secondary 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) 6 weeks of treatment No
Secondary 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) 6 weeks of treatment No
Secondary 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) 6 weeks of treatment No
Secondary 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) 6 weeks of treatment No
Secondary 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) 6 weeks of treatment No
Secondary 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) 6 weeks of treatment No
Secondary 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). 6 weeks of treatment Yes
Secondary 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. 6 weeks of treatment Yes
Secondary 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. 6 week of treatments Yes
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