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Completed

NCT Number: NCT00789854

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

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders Treatment Resistant Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Garran, Australian Capital Territory, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quetiapine XR

Drug

300 mg once daily (od)

Other names: Seroquel XR

Lithium Carbonate

Drug

900 mg once daily (od)

Other names: Quilonum Retard

SSRI/Venlafaxine

Drug

SSRI - doses within label, Venlafaxine dose up to 225 mg/day

Primary outcomes

  1. 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)

    Time frame: 6 weeks treatment

    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.

  2. 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)

    Time frame: 6 weeks of treatment

    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 outcomes

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

    Time frame: 6 weeks of treatment

    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.

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

    Time frame: 6 weeks of treatment

    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.

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

    Time frame: 6 weeks of treatment

    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.

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

    Time frame: 6 weeks of treatment

    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.

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

    Time frame: 6 weeks of treatment

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

    Time frame: 6 week of treatments

    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

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

    Time frame: 6 weeks of treatment

    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

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

    Time frame: 6 weeks of treatment

    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

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

    Time frame: 6 weeks of treatment

    Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where lower value shows a larger improvement.

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

    Time frame: 6 weeks of treatment

    Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.

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

    Time frame: 6 weeks of treatment

    Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.

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

    Time frame: 6 weeks of treatment

    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.

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

    Time frame: 6 weeks of treatment

    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.

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

    Time frame: 6 weeks of treatment

    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.

  15. Change in Beck Depression Inventory (BDI)

    Time frame: 6 weeks of treatment

    Self-rating assessment of depressive symptoms using Beck Depression Inventory (BDI). Scale from 0-63, where a lower value shows a larger improvement.

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

    Time frame: 6 weeks of treatment

    Self-rating assessment of pain using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.

  17. Change in Anxiety Measured by Visual Analog Scale (VAS)

    Time frame: 6 weeks of treatment

    Self-rating assessment of anxiety using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.

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

    Time frame: 6 weeks of treatment

    Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)

  19. Change in Anxiety Measured by STAI, Trait Anxiety Inventory

    Time frame: 6 weeks of treatment

    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)

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

    Time frame: 6 weeks of treatment

    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)

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

    Time frame: 6 weeks of treatment

    Self-rated sleeping quality measured by PSQI (Scale 0-21, subscales 0-3, 18 questions, where a lower value shows a larger improvement)

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

    Time frame: 6 weeks of treatment

    Self rating assessment of quality in life using SF-36, mental component (Scale 0-100, where a higher value shows a larger improvement)

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

    Time frame: 6 weeks of treatment

    Self rating assessment of quality in life using SF-36, physical component (Scale 0-100, where a higher value shows a larger improvement)

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

    Time frame: 6 weeks of treatment

    Self rating assessment of quality in life using EQ-5D utility (Scale 0-100, where a higher value shows a larger improvement)

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

    Time frame: 6 weeks of treatment

    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)

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

    Time frame: 6 weeks of treatment

    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).

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

    Time frame: 6 weeks of treatment

    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.

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

    Time frame: 6 week of treatments

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: RUBY

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 13, 2008
Registry last updated
May 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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