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Proven effective in improving overall depressive symptoms of bipolar I1-5
Change in MADRS total score in bipolar I depression studies
Study 7 (N=431)1-3
It is unknown if the statistically significant differences observed at time points earlier than Week 6 represent clinically relevant treatment effects.
Two 6-week and one 8-week randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of VRAYLAR in adult patients (18-65 years old) who met DSM-IV-TR and DSM-5 criteria for depressive episodes associated with bipolar I disorder. The primary statistical analyses were conducted using an MMRM approach. In each study, the primary endpoint was the LS mean change from baseline in MADRS total score at the end of Week 6.1,3-5
VRAYLAR studies included the types of bipolar I depression patients that you may see in your practice
Baseline characteristics across the 3 pivotal bipolar I depression studies
VRAYLAR was evaluated as a monotherapy1,3-5
- Studies included bipolar I depression patients with or without manic symptoms3-6§
- ~8 out of 10 patients in the trials rated their current or most recent depressive episode associated with bipolar I as moderate2
of VRAYLAR-treated patients were previously on antidepressants (n=527/939)2
of VRAYLAR-treated patients were previously on mood stabilizers (n=493/939)2
of patients had moderate to severe anhedonia symptoms (n=949/1383)2||
of patients had anxiety symptoms (n=894/1383)7¶
§Concurrent manic symptoms defined as a YMRS total score ≥4. Patients with a YMRS total score >10 (Study 7) or >12 (Studies 8 and 9) at baseline were excluded from these studies.3-6
||Overall, 69% of patients had MADRS anhedonia subscale scores of ≥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).2
¶Overall, 65% of patients treated with cariprazine 1.5 mg/day or 3 mg/day had higher anxiety symptoms at baseline, defined as a HAM-D anxiety/somatization subscale score of ≥7.7
Change in MADRS total score in bipolar I depression studies
Study 8 (N=474)1,2,4
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It is unknown if the statistically significant differences observed at time points earlier than Week 6 represent clinically relevant treatment effects.
Two 6-week and one 8-week randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of VRAYLAR in adult patients (18-65 years old) who met DSM-IV-TR and DSM-5 criteria for depressive episodes associated with bipolar I disorder. The primary statistical analyses were conducted using an MMRM approach. In each study, the primary endpoint was the LS mean change from baseline in MADRS total score at the end of Week 6.1,3-5
VRAYLAR studies included the types of bipolar I depression patients that you may see in your practice
Baseline characteristics across the 3 pivotal bipolar I depression studies
VRAYLAR was evaluated as a monotherapy1,3-5
- Studies included bipolar I depression patients with or without manic symptoms3-6§
- ~8 out of 10 patients in the trials rated their current or most recent depressive episode associated with bipolar I as moderate2
of VRAYLAR-treated patients were previously on antidepressants (n=527/939)2
of VRAYLAR-treated patients were previously on mood stabilizers (n=493/939)2
of patients had moderate to severe anhedonia symptoms (n=949/1383)2||
of patients had anxiety symptoms (n=894/1383)7¶
§Concurrent manic symptoms defined as a YMRS total score ≥4. Patients with a YMRS total score >10 (Study 7) or >12 (Studies 8 and 9) at baseline were excluded from these studies.3-6
||Overall, 69% of patients had MADRS anhedonia subscale scores of ≥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).2
¶Overall, 65% of patients treated with cariprazine 1.5 mg/day or 3 mg/day had higher anxiety symptoms at baseline, defined as a HAM-D anxiety/somatization subscale score of ≥7.7
Change in MADRS total score in bipolar I depression studies
Study 9 (N=478)1,2,5
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It is unknown if the statistically significant differences observed at time points earlier than Week 6 represent clinically relevant treatment effects.
Two 6-week and one 8-week randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of VRAYLAR in adult patients (18-65 years old) who met DSM-IV-TR and DSM-5 criteria for depressive episodes associated with bipolar I disorder. The primary statistical analyses were conducted using an MMRM approach. In each study, the primary endpoint was the LS mean change from baseline in MADRS total score at the end of Week 6.1,3-5
VRAYLAR studies included the types of bipolar I depression patients that you may see in your practice
Baseline characteristics across the 3 pivotal bipolar I depression studies
VRAYLAR was evaluated as a monotherapy1,3-5
- Studies included bipolar I depression patients with or without manic symptoms3-6§
- ~8 out of 10 patients in the trials rated their current or most recent depressive episode associated with bipolar I as moderate2
of VRAYLAR-treated patients were previously on antidepressants (n=527/939)2
of VRAYLAR-treated patients were previously on mood stabilizers (n=493/939)2
of patients had moderate to severe anhedonia symptoms (n=949/1383)2||
of patients had anxiety symptoms (n=894/1383)7¶
§Concurrent manic symptoms defined as a YMRS total score ≥4. Patients with a YMRS total score >10 (Study 7) or >12 (Studies 8 and 9) at baseline were excluded from these studies.3-6
||Overall, 69% of patients had MADRS anhedonia subscale scores of ≥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).2
¶Overall, 65% of patients treated with cariprazine 1.5 mg/day or 3 mg/day had higher anxiety symptoms at baseline, defined as a HAM-D anxiety/somatization subscale score of ≥7.7
Observed reduction in anhedonia subscale score in patients with bipolar I depression at Week 6 in a post-hoc analysis2#**
Change from baseline in anhedonia (loss of interest or pleasure) subscale score
Intent-to-treat population (N=1383)
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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.
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).2
#This was a post-hoc analysis of the primary endpoint (MADRS change from baseline to Week 6) and was not adjusted for multiple comparisons.2
**The primary endpoint was change from baseline to Week 6 in MADRS total score. Results of pooled data from two 6-week and one 8-week pivotal, multicenter, randomized, placebo-controlled trials in adults with bipolar I depression (N=1383). Patients were randomized in 3 arms: VRAYLAR 1.5 mg, VRAYLAR 3 mg, or placebo.2-5
Results of pooled data from two 6-week and one 8-week pivotal, multicenter, randomized, placebo-controlled trials. Patients in the ITT population (N=1383) were treated with either placebo (n=460) or VRAYLAR (n=923). This was a post-hoc analysis of the primary endpoint (MADRS change from baseline to Week 6) and was not adjusted for multiple comparisons.
Change in functional outcomes across autonomy, occupational functioning, cognitive functioning, financial issues, relationships, and leisure time
Additional efficacy endpoint in one pivotal bipolar I depression trial: Change in Functioning Assessment Short Test (FAST) total score at Week 82
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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 was approved based on the primary endpoint, mean change in MADRS total score from baseline at Week 6.1
This 8-week, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of VRAYLAR in adult patients (18-65 years old) who met DSM-IV-TR criteria for depressive episodes associated with bipolar I disorder. The primary statistical analysis was conducted using an MMRM approach. The primary endpoint was the LS mean change from baseline in MADRS total score at the end of Week 6.1,3
Observed reduction in individual MADRS item scores at Week 6 in a post-hoc analysis2,9
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.
VRAYLAR was approved based on the primary endpoint, mean change in MADRS total score from baseline at Week 6.1
A post-hoc analysis of data pooled from 3 randomized, placebo-controlled, double-blind studies of adult patients with bipolar I disorder. Patients in the ITT population (N=1383) were treated with either placebo (n=460) or VRAYLAR (n=923). VRAYLAR doses 1.5-3 mg/day were pooled for analysis. Mean change from baseline at 6 weeks on individual MADRS items were analyzed using an MMRM approach.9
Observed reduction in anxiety symptom score in patients with bipolar I depression at Week 64,5
Additional efficacy endpoint in 2 pivotal bipolar I depression trials: Mean change from baseline to Week 6 in Hamilton Anxiety Scale (HAM-A)
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VRAYLAR is indicated in adults for the treatment of bipolar I depression. VRAYLAR is not approved for the treatment of anxiety disorders.1
HAM-A was an additional efficacy endpoint in two 6-week bipolar I depression trials. This prespecified endpoint was not adjusted for multiplicity, therefore, treatment differences cannot be regarded as statistically significant.4,5
Results from two phase 3 6-week randomized, double-blind, placebo-controlled, parallel-group, fixed-dose studies in adults with bipolar I depression. Patients were randomized in 3 arms: VRAYLAR 1.5 mg/day, VRAYLAR 3 mg/day, or placebo. This was an additional prespecified endpoint and was not adjusted for multiple comparisons.4,5
DSM=Diagnostic and Statistical Manual of Mental Disorders; HAM-A=Hamilton Anxiety Rating Scale; HAM-D=Hamilton Depression Rating Scale; ITT=intent-to-treat; LS=least squares; MADRS=Montgomery-Asberg Depression Rating Scale; MMRM=mixed-effects model for repeated measures; SD=standard deviation; TR=text revision; YMRS=Young Mania Rating Scale.