Phase 3
N=688
Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients
Major Depressive Disorder · Treatment Resistant Depression
Bottom Line
View on ClinicalTrials.gov: NCT00789854 ↗Enrolled (actual)
688
Serious AEs
1.7%
Results posted
May 2012
Primary outcome: 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) — -16.2; -17.2; -14.9 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Quetiapine XR (Drug); Lithium carbonate (Drug); SSRI/Venlafaxine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
-16.2; -17.2; -14.9 | — |
| 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) |
-13.9; -15.1; -13.3 | 0.0489 sig |
| SECONDARY Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients |
53; 73; 60 | — |
| SECONDARY Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure |
22; 42; 31 | — |
| SECONDARY Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure |
31; 31; 29 | — |
| SECONDARY Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8 |
35; 58; 45 | — |
| SECONDARY Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12 |
67; 89; 73 | — |
| SECONDARY Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients |
114; 120; 102 | — |
| SECONDARY Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure |
54; 65; 53 | — |
| SECONDARY Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure |
60; 55; 49 | — |
| SECONDARY Responder: Clinical Global Impression Improvement (CGI-I) Item 2, All Patients |
-1.54; -1.85; -1.58 | — |
| SECONDARY Responder: Clinical Global Impression Improvement (CGI)-I Item 2, Patients With One Previous Treatment Failure |
-1.42; -1.91; -1.62 | — |
| SECONDARY Responder: Clinical Global Impression Improvement (CGI-I) Item 2, Patients With Two Previous Treatment Failure |
-1.67; -1.79; -1.54 | — |
| SECONDARY Change in Clinical Global Impression Scale (CGI-S), All Patients |
-1.43; -1.65; -1.49 | — |
| SECONDARY Change in Clinical Global Impression Scale (CGI-S), Patients With One Previous Treatment Failure |
-1.45; -1.82; -1.59 | — |
| SECONDARY Change in Clinical Global Impression Scale (CGI-S), Patients With Two Previous Treatment Failure |
-1.52; -1.55; -1.45 | — |
| SECONDARY Change in Beck Depression Inventory (BDI) |
-11.7; -13.5; -12.2 | — |
| SECONDARY Change in Pain, Measured by Visual Analog Scale (VAS) |
-9.47; -8.03; -8.3 | — |
| SECONDARY Change in Anxiety Measured by Visual Analog Scale (VAS) |
-21.2; -23.4; -20.6 | — |
| SECONDARY Change in Anxiety Measured by State-Trait Anxiety Inventory (STAI), State Anxiety Inventory |
-0.62; 0.014; -0.87 | — |
| SECONDARY Change in Anxiety Measured by STAI, Trait Anxiety Inventory |
-1.01; -1.36; -1.39 | — |
| SECONDARY Change in Sleep Quality Measured by Montgomery Asberg Depression Rating Scale (MADRS), Item 4 |
-2.2; -2.4; -1.63 | — |
| SECONDARY Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI) |
-4.77; -4.96; -3.51 | — |
| SECONDARY Change in Quality of Life Measured by Short-form Health Survey (SF-36), Mental Component |
9.59; 10.77; 9.66 | — |
| SECONDARY Change in Quality of Life Measured by Short-form Health Survey (SF-36), Physical Component |
5.224; 5.065; 4.566 | — |
| SECONDARY Change in Quality of Life Measured by Health Questionnaire EQ-5D as Utility |
0.184; 0.224; 0.208 | — |
| SECONDARY Change in Work Productivity and Activity Impairment: General Health (WPAI:GH) |
-233; -185; -299 | — |
| SECONDARY Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, All Patients |
135; 146; 131 | — |
| SECONDARY Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With One Previous Treatment Failure |
67; 75; 69 | — |
| SECONDARY Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With Two Previous Treatment Failures |
68; 71; 62 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00789854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.