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Proven effective in improving overall depressive symptoms as an antidepressant add-on for MDD
MADRS total score reduction for VRAYLAR + ADT vs placebo + ADT1,2
6-week fixed dose study (N=751)
‡Not prespecified endpoint and not adjusted for multiplicity.
VRAYLAR CAN PROVIDE A BOOST of additional antidepressant efficacy at 6 weeks when added to an antidepressant for MDD partial responders
| Duration | N | Design | Doses Studied | Control | Primary Endpoint |
|---|---|---|---|---|---|
| 6-Week | 751 | Fixed Dose | 1.5 mg/day + ADT; 3 mg/day + ADT |
Placebo + ADT | Mean change from baseline in MADRS total score at the end of Week 6 |
| 8-Week | 808 | Flexible Dose | 1-2 mg/day + ADT Mean VRAYLAR dose was 1.4 mg/day; 2-4.5 mg/day + ADT Mean VRAYLAR dose was 2.6 mg/day |
Placebo + ADT | Mean change from baseline in MADRS total score at the end of Week 8 |
Both adjunctive MDD studies were randomized, double-blind, placebo-controlled, and evaluated the efficacy and safety of VRAYLAR in adult patients (mean age of 45 years, range 18-65 years) who met DSM-IV-TR or DSM-5 criteria for MDD, with or without symptoms of anxiety, and had an inadequate response to 1 to 3 courses of prior antidepressant (ADT) therapy.§
§Inadequate response during antidepressant treatment was defined as less than 50% improvement to antidepressant treatment of adequate dose and duration.
The VRAYLAR studies included the types of major depressive disorder patients you may see in your practice
Baseline characteristics across the 2 pivotal adjunctive MDD studies1,3,4
Most patients had moderate to severe depressive symptoms at baseline with ADT
Baseline mean MADRS total scores:
6-week MDD trial (pooled) = 32.5
- VRAYLAR 1.5 mg/day + ADT = 32.8
- VRAYLAR 3 mg/day + ADT = 32.7
- Placebo + ADT = 31.9
8-week MDD flexible-dose trial
- VRAYLAR 1-2 mg/day + ADT = 29.0
- VRAYLAR 2-4.5 mg/day + ADT = 29.3
- Placebo + ADT = 28.9
Patients enrolled were taking the most commonly used antidepressants, including||:
- sertraline
- fluoxetine
- bupropion
- escitalopram
- duloxetine
- citalopram
- desvenlafaxine
- venlafaxine
had an inadequate response to their first ADT in the current episode across both MDD studies
had anhedonia symptoms that were moderate to severe at baseline in the 6-week fixed-dose trial¶
had anxiety symptoms at baseline in the 6-week fixed-dose trial#
||These are not all of the ADTs patients were taking prior to and during the VRAYLAR MDD studies. Please see publications for complete list.3
¶584/751 (77.8%) patients had MADRS anhedonia subscale scores ≥18. The MADRS anhedonia subscale is the sum of the following items: 1 (apparent sadness), 2 (reported sadness), 6 (concentration difficulties), 7 (lassitude), and 8 (inability to feel).4
#Overall, 83% of patients had anxiety symptoms at baseline, defined as a score of ≥7 at baseline on the HAM-D anxiety/somatization factor. Anxiety/somatization factor comprises the following 6 items from the HAM-D: psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight.3,5
MADRS total score reduction for VRAYLAR + ADT vs placebo + ADT1,3
8-week flexible dose study (N=808)
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VRAYLAR CAN PROVIDE A BOOST of additional antidepressant efficacy at 8 weeks when added to an antidepressant for MDD partial responders
| Duration | N | Design | Doses Studied | Control | Primary Endpoint |
|---|---|---|---|---|---|
| 6-Week | 751 | Fixed Dose | 1.5 mg/day + ADT; 3 mg/day + ADT |
Placebo + ADT | Mean change from baseline in MADRS total score at the end of Week 6 |
| 8-Week | 808 | Flexible Dose | 1-2 mg/day + ADT Mean VRAYLAR dose was 1.4 mg/day; 2-4.5 mg/day + ADT Mean VRAYLAR dose was 2.6 mg/day |
Placebo + ADT | Mean change from baseline in MADRS total score at the end of Week 8 |
Both adjunctive MDD studies were randomized, double-blind, placebo-controlled, and evaluated the efficacy and safety of VRAYLAR in adult patients (mean age of 45 years, range 18-65 years) who met DSM-IV-TR or DSM-5 criteria for MDD, with or without symptoms of anxiety, and had an inadequate response to 1 to 3 courses of prior antidepressant (ADT) therapy.§
§Inadequate response during antidepressant treatment was defined as less than 50% improvement to antidepressant treatment of adequate dose and duration.
The VRAYLAR studies included the types of major depressive disorder patients you may see in your practice
Baseline characteristics across the 2 pivotal adjunctive MDD studies1,3,4
Most patients had moderate to severe depressive symptoms at baseline with ADT
Baseline mean MADRS total scores:
6-week MDD trial (pooled) = 32.5
- VRAYLAR 1.5 mg/day + ADT = 32.8
- VRAYLAR 3 mg/day + ADT = 32.7
- Placebo + ADT = 31.9
8-week MDD flexible-dose trial
- VRAYLAR 1-2 mg/day + ADT = 29.0
- VRAYLAR 2-4.5 mg/day + ADT = 29.3
- Placebo + ADT = 28.9
Patients enrolled were taking the most commonly used antidepressants, including‖:
- sertraline
- fluoxetine
- bupropion
- escitalopram
- duloxetine
- citalopram
- desvenlafaxine
- venlafaxine
had an inadequate response to their first ADT in the current episode across both MDD studies
had anhedonia symptoms that were moderate to severe at baseline in the 6-week fixed-dose trial¶
had anxiety symptoms at baseline in the 6-week fixed-dose trial#
‖These are not all of the ADTs patients were taking prior to and during the VRAYLAR MDD studies. Please see publications for complete list.3
¶584/751 (77.8%) patients had MADRS anhedonia subscale scores ≥18. The MADRS anhedonia subscale is the sum of the following items: 1 (apparent sadness), 2 (reported sadness), 6 (concentration difficulties), 7 (lassitude), and 8 (inability to feel).4
#Overall, 83% of patients had anxiety symptoms at baseline, defined as a score of ≥7 at baseline on the HAM-D anxiety/somatization factor. Anxiety/somatization factor comprises the following 6 items from the HAM-D: psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight.3,5
Observed reduction in MADRS anhedonia subscale score in patients with major depressive disorder at Week 6 in a post-hoc analysis4**
Change from baseline in MADRS anhedonia (loss of interest or pleasure) subscale score (N=751)
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These analyses were not prespecified endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
VRAYLAR is indicated in adults as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).1
MADRS anhedonia subscale is the sum of the following items: 1 (apparent sadness), 2 (reported sadness), 6 (concentration difficulties), 7 (lassitude), and 8 (inability to feel).
**This was a post-hoc analysis of the primary endpoint (MADRS change from baseline to Week 6) and was not adjusted for multiplicity. The primary endpoint was change from baseline to Week 6 in MADRS total score. Results of a representative, pivotal, multicenter, randomized, placebo-controlled 6-week trial in adults with MDD (N=751). Patients were randomized in 3 arms: VRAYLAR 1.5 mg, VRAYLAR 3 mg, or placebo + ongoing ADT.1,4
| Duration | N | Design | Doses Studied | Control | Primary Endpoint |
|---|---|---|---|---|---|
| 6-Week | 751 | Fixed Dose | 1.5 mg/day + ADT; 3 mg/day + ADT |
Placebo + ADT | Mean change from baseline in MADRS total score at the end of Week 6 |
A post-hoc analysis of data from 1 multicenter, randomized, placebo-controlled, double-blind study of adults with MDD who had an inadequate response to ADT alone (n=751). Patients in the mITT population (n=751) were either treated with placebo + ADT (n=249), VRAYLAR 1.5 mg/day + ADT, or VRAYLAR 3 mg/day + ADT (n=502). The primary efficacy parameter was change from baseline at 6 weeks in MADRS total score and was analyzed using an MMRM approach.
Observed increase in health-related quality of life in patients with major depressive disorder at Week 6 in a health outcomes measure3,6
Mean change from baseline to Week 6 in SF-12v2 component summary scores
The SF-12v2 measures health-related quality of life and consists of two separate summary scores:
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VRAYLAR is indicated in adults as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).1
The 12-item Short Form version 2 Health Survey (SF-12v2) was a prespecified Health Outcome Measure in the 6-week adjunctive MDD trial. These data were not adjusted for multiplicity; therefore, treatment differences cannot be regarded as statistically significant.
Results from 1 multicenter, randomized, placebo-controlled, double-blind study of adults with MDD who had an inadequate response to ADT alone (n=751). Patients in the mITT population (n=751) were either treated with placebo + ADT (n=249), VRAYLAR 1.5 mg/day + ADT (n=250), or VRAYLAR 3 mg/day + ADT (n=252). The primary efficacy endpoint was change from baseline at 6 weeks in MADRS total score.3,6
| Duration | N | Design | Doses Studied | Control | Primary Endpoint |
|---|---|---|---|---|---|
| 6-Week | 751 | Fixed Dose | 1.5 mg/day + ADT; 3 mg/day + ADT |
Placebo + ADT | Mean change from baseline in MADRS total score at the end of Week 6 |
A post-hoc analysis of data from 1 multicenter, randomized, placebo-controlled, double-blind study of adults with MDD who had an inadequate response to ADT alone (n=751). Patients in the mITT population (n=751) were either treated with placebo + ADT (n=249), VRAYLAR 1.5 mg/day + ADT, or VRAYLAR 3 mg/day + ADT (n=502). The primary efficacy parameter was change from baseline at 6 weeks in MADRS total score and was analyzed using an MMRM approach.
Observed reduction in individual MADRS item scores at Week 6 in a post-hoc analysis1,3††‡‡
MADRS items (Scored 0-6)
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These analyses were not prespecified endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
††This was a post-hoc analysis of the primary endpoint (MADRS change from baseline to Week 6) and was not adjusted for multiple comparisons.
‡‡The primary endpoint was change from baseline to Week 6 in MADRS total score. Results of a representative, pivotal, multicenter, randomized, placebo-controlled 6-week trial in adults with MDD (N=751). Patients were randomized in 3 arms: cariprazine 1.5 mg, cariprazine 3 mg, or placebo + ongoing ADT.1,3
| Duration | N | Design | Doses Studied | Control | Primary Endpoint |
|---|---|---|---|---|---|
| 6-Week | 751 | Fixed Dose | 1.5 mg/day + ADT; 3 mg/day + ADT |
Placebo + ADT | Mean change from baseline in MADRS total score at the end of Week 6 |
A post-hoc analysis of data from 1 multicenter, randomized, placebo-controlled, double-blind study of adults with MDD who had an inadequate response to ADT alone (n=751). Patients in the mITT population (n=751) were either treated with placebo + ADT (n=249), VRAYLAR 1.5 mg/day + ADT, or VRAYLAR 3 mg/day + ADT (n=502). The primary efficacy parameter was change from baseline at 6 weeks in MADRS total score and was analyzed using an MMRM approach.
Observed reduction in anxiety symptom score in patients with major depressive disorder at Week 62
Additional efficacy endpoint: Mean change from baseline to Week 6 in HAM-A total score
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VRAYLAR is indicated in adults as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). VRAYLAR is not approved for the treatment of anxiety disorders.1
HAM-A was an additional efficacy endpoint in the 6-week adjunctive MDD trial. This prespecified endpoint was not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
Results from 1 multicenter, randomized, placebo-controlled, double-blind study of adults with MDD who had an inadequate response to ADT alone (n=751). Patients in the mITT population (n=751) were either treated with placebo + ADT (n=249), VRAYLAR 1.5 mg/day + ADT (n=250), or VRAYLAR 3 mg/day + ADT (n=252). The primary efficacy endpoint was change from baseline at 6 weeks in MADRS total score.2
| Duration | N | Design | Doses Studied | Control | Primary Endpoint |
|---|---|---|---|---|---|
| 6-Week | 751 | Fixed Dose | 1.5 mg/day + ADT; 3 mg/day + ADT |
Placebo + ADT | Mean change from baseline in MADRS total score at the end of Week 6 |
The 6-week adjunctive MDD study was randomized, double-blind, placebo-controlled, and evaluated adult patients (mean age of 45 years, range 18 to 65 years) who met DSM IV-TR or DSM-5 criteria for MDD, with or without symptoms of anxiety, and had an inadequate response to 1 to 3 courses of prior antidepressant therapy.§§
§§Inadequate response during antidepressant treatment was defined as less than 50% improvement to antidepressant treatment of adequate dose and adequate duration.2
ADT=antidepressant therapy; DSM=Diagnostic and Statistical Manual of Mental Disorders; HAM-A=Hamilton Anxiety Rating Scale; HAM-D=Hamilton Depression Rating Scale; LS=least squares; MADRS=Montgomery-Asberg Depression Rating Scale; MDD=major depressive disorder; mITT=modified intent-to-treat; MMRM=mixed-effects model for repeated measures; NS=not significant; SF-12v2=Short Form version 2 Health Survey; TR=text revision.