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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder; Treatment Resistant Depression

Treatments: Drug: SSRI/Venlafaxine; Drug: Lithium carbonate; Drug: Quetiapine XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00789854

D1443L00044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 688 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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688 participants in 3 patient groups

Add-on Quetiapine XR+SSRI/Venlafaxine

Active Comparator group

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.

Treatment:

Drug: Quetiapine XR

Drug: SSRI/Venlafaxine

Add-on Lithium+SSRI/Venlafaxine

Active Comparator group

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.

Treatment:

Drug: Lithium carbonate

Drug: SSRI/Venlafaxine

Monotherapy Quetiapine XR

Active Comparator group

Description:

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

Treatment:

Drug: Quetiapine XR