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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder; Treatment Resistant Depression

Intervention: Quetiapine XR (Drug); Lithium carbonate (Drug); SSRI/Venlafaxine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Michael Bauer, professor, Principal Investigator, Affiliation: Germany
Birgit Ekholm, PhD, Study Director, Affiliation: AstraZeneca MC Sweden

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.

Clinical Details

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

Primary outcome:

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 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)

Secondary outcome:

Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients

Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure

Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure

Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8

Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12

Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients

Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure

Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure

Responder: Clinical Global Impression Improvement (CGI-I) Item 2, All Patients

Responder: Clinical Global Impression Improvement (CGI)-I Item 2, Patients With One Previous Treatment Failure

Responder: Clinical Global Impression Improvement (CGI-I) Item 2, Patients With Two Previous Treatment Failure

Change in Clinical Global Impression Scale (CGI-S), All Patients

Change in Clinical Global Impression Scale (CGI-S), Patients With One Previous Treatment Failure

Change in Clinical Global Impression Scale (CGI-S), Patients With Two Previous Treatment Failure

Change in Beck Depression Inventory (BDI)

Change in Pain, Measured by Visual Analog Scale (VAS)

Change in Anxiety Measured by Visual Analog Scale (VAS)

Change in Anxiety Measured by State-Trait Anxiety Inventory (STAI), State Anxiety Inventory

Change in Anxiety Measured by STAI, Trait Anxiety Inventory

Change in Sleep Quality Measured by Montgomery Asberg Depression Rating Scale (MADRS), Item 4

Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)

Change in Quality of Life Measured by Short-form Health Survey (SF-36), Mental Component

Change in Quality of Life Measured by Short-form Health Survey (SF-36), Physical Component

Change in Quality of Life Measured by Health Questionnaire EQ-5D as Utility

Change in Work Productivity and Activity Impairment: General Health (WPAI:GH)

Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, All Patients

Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With One Previous Treatment Failure

Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With Two Previous Treatment Failures

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Research Site, Graz, Austria

Research Site, Klagenfurt, Austria

Research Site, Salzburg, Austria

Research Site, Wels, Austria

Research Site, Wiener NEUSTADT, Austria

Research Site, Wien, Austria

Research Site, Assebroek, Belgium

Research Site, Diest, Belgium

Research Site, Liege, Belgium

Research Site, Tielt, Belgium

Research Site, Kardjali, Bulgaria

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Research Site, Ruse, Bulgaria

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Research Site, Esbjerg N, Denmark

Research Site, Frederiksberg, Denmark

Research Site, Odense, Denmark

Research Site, Aachen, Germany

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Additional Information

Starting date: November 2008
Last updated: April 23, 2012

Page last updated: August 23, 2015

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