Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT01058096 | Bipolar Disorder | Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 Baseline, Week 3 | Cariprazine | -19.6 score on a scale (±0.9 Standard Error) |
| Placebo | -15.3 score on a scale (±0.9 Standard Error) | |||
| NCT01058668 | Mania | Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 Baseline, Week 3 | Cariprazine (3-6 mg/Day) | -18.6 score on a scale (±0.8 Standard Error) |
| Cariprazine (6-12 mg/Day) | -18.5 score on a scale (±0.8 Standard Error) | |||
| Placebo | -12.5 score on a scale (±0.8 Standard Error) | |||
| NCT01059539 | Mania | Change From Baseline in the YMRS Total Score at Week 16 Baseline to Week 16 | Cariprazine 3-12 mg/Day for 16 Weeks | -15.2 Units on a scale (±9.2 Standard Deviation) |
| NCT01104766 | Schizophrenia | Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. Baseline to Week 6 | Aripiprazole 10.0 mg | -21.2 Units on a Scale (±1.4 Standard Error) |
| Cariprazine 3.0 mg | -20.2 Units on a Scale (±1.5 Standard Error) | |||
| Cariprazine 6.0mg | -23.0 Units on a Scale (±1.5 Standard Error) | |||
| Placebo | -14.3 Units on a Scale (±1.5 Standard Error) | |||
| NCT01104779 | Schizophrenia | Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score Baseline to Week 6 | Cariprazine (3-6 mg/Day) | -22.8 Units on a Scale (±1.6 Standard Error) |
| Cariprazine (6-9 mg/Day) | -25.9 Units on a Scale (±1.7 Standard Error) | |||
| Placebo | -16.0 Units on a Scale (±1.6 Standard Error) | |||
| NCT01104792 | Schizophrenia | Change From Baseline to Week 48 in the PANSS Total Score Baseline to Week 48 | Cariprazine | -5.0 Units on a scale (±14.0 Standard Deviation) |
| Cariprazine | 66.5 Units on a scale (±12.1 Standard Deviation) | |||
| NCT01412060 | Schizophrenia | Time From Baseline to the First Symptom Relapse During the Double-blind Phase Up to 34 Weeks and Bi-Weekly thereafter until Week 92 | Cariprazine | 224 Days |
| Placebo | 92 Days | |||
| NCT01715805 | Depressive Disorder, Major | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period Baseline (Week 8) to Week 16 | Cariprazine + ADT (Double-Blind) | -7.7 score on a scale (±0.5 Standard Error) |
| Placebo + ADT (Double-Blind) | -7.5 score on a scale (±0.5 Standard Error) | |||
| NCT01715805 | Depressive Disorder, Major | Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period Baseline (Week 8) | Cariprazine + ADT (Double-Blind) | 25.4 score on a scale (±5.5 Standard Deviation) |
| Placebo + ADT (Double-Blind) | 25.2 score on a scale (±6.1 Standard Deviation) | |||
| NCT01838876 | Depression | Change From Baseline in the Arizona Sexual Experiences Scale (ASEX) Score Baseline (Lead-in study Baseline for roll-over participants and prior to first dose of this study for new participants) to End of Treatment (Up to Week 26) in this study | Cariprazine + ADT (Female) | -0.9 score on a scale (±4.4 Standard Deviation) |
| Cariprazine + ADT (Female) | 20.1 score on a scale (±5.9 Standard Deviation) | |||
| Cariprazine + ADT (Male) | -0.1 score on a scale (±4.6 Standard Deviation) | |||
| Cariprazine + ADT (Male) | 17.2 score on a scale (±5.5 Standard Deviation) | |||
| NCT01838876 | Depression | Number of Participants in the Most Severe Suicidal Ideation and Suicidal Behavior Recorded on the C-SSRS During the Treatment Period Baseline (Lead-in study Baseline for roll-over participants and prior to first dose in this study for new participants) to Week 26 in this study | Cariprazine + ADT | 1 participants |
| Cariprazine + ADT | 0 participants | |||
| Cariprazine + ADT | 6 participants | |||
| Cariprazine + ADT | 3 participants | |||
| Cariprazine + ADT | 27 participants | |||
| Cariprazine + ADT | 344 participants | |||
| Cariprazine + ADT | 1 participants | |||
| Cariprazine + ADT | 0 participants | |||
| Cariprazine + ADT | 308 participants | |||
| Cariprazine + ADT | 37 participants | |||
| Cariprazine + ADT | 1 participants | |||
| NCT01838876 | Depression | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters Baseline (Week 0) to up to 26 weeks in the Treatment Period | Cariprazine + ADT | 0 Participants |
| NCT01838876 | Depression | Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG) Baseline (Week 0) to up to 26 weeks | Cariprazine + ADT | 1 Participants |
| NCT01838876 | Depression | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters Baseline (Week 0) to up to 26 weeks in the Treatment Period plus a 2-week Safety Follow-up Period (Up to 28 weeks) | Cariprazine + ADT | 0 Participants |
| NCT01838876 | Depression | Number of Participants With Extrapyramidal Symptom (EPS)-Related TEAEs First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks) | Cariprazine + ADT | 98 Participants |
| NCT01838876 | Depression | Number of Participants With Newly Emergent Adverse Events (NEAEs) in the Safety Follow-up Period 2 weeks following the 26-week Treatment Period | Cariprazine + ADT | 20 Participants |
| NCT01838876 | Depression | Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period First dose of study drug to last dose of study drug in the 26-week Treatment Period and within 30 days of last dose of study drug for participants who did not participate in the 2-week Safety Follow-up Period (Up to 30 weeks) | Cariprazine + ADT | 274 Participants |
| NCT01838876 | Depression | Number of Participants With Treatment-Emergent Ocular Events First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks) | Cariprazine + ADT | 1 Participants |
| NCT02670538 | Depression | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Baseline (Week 0) to Week 6 | Cariprazine 1.5 mg | -14.8 score on a scale (±0.76 Standard Error) |
| Cariprazine 3.0 mg | -14.1 score on a scale (±0.78 Standard Error) | |||
| Placebo | -12.4 score on a scale (±0.75 Standard Error) | |||
| NCT02670551 | Depression | Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6 Baseline (Week 0) to Week 6 | Cariprazine 1.5 mg | -15.1 score on a scale (±0.77 Standard Error) |
| Cariprazine 3.0 mg | -15.6 score on a scale (±0.76 Standard Error) | |||
| Placebo | -12.6 score on a scale (±0.76 Standard Error) | |||
| NCT03573297 | Depression | Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period From Week 16 to Week 55 | Double-Blind Cariprazine 1.5 mg QD | NA days |
| Double-Blind Cariprazine 1.5 mg QD | NA days | |||
| Double-Blind Cariprazine 1.5 mg QD | NA days | |||
| Double-Blind Cariprazine 3.0 mg QD | NA days | |||
| Double-Blind Cariprazine 3.0 mg QD | NA days | |||
| Double-Blind Cariprazine 3.0 mg QD | NA days | |||
| Double-Blind Placebo QD | NA days | |||
| Double-Blind Placebo QD | NA days | |||
| Double-Blind Placebo QD | NA days | |||
| NCT03593213 | Schizophrenia | Time to First Relapse During Double-blind Treatment Period Randomization (Week 18) to End of Treatment (Week 44) | Cariprazine 3.0 mg/Day (Double-blind Treatment Period) | NA days |
| Cariprazine 4.5 mg/Day (Double-blind Treatment Period) | NA days | |||
| Placebo (Double-blind Treatment Period) | NA days | |||
| NCT03738215 | Depressive Disorder, Major | Total Score Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Baseline and Week 6 | Cariprazine 1.5 mg/Day + ADT | -14.1 score on a scale (±0.70 Standard Error) |
| Cariprazine 3 mg/Day + ADT | -13.1 score on a scale (±0.70 Standard Error) | |||
| Placebo + ADT | -11.5 score on a scale (±0.70 Standard Error) | |||
| NCT03739203 | Depressive Disorder, Major | Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score Baseline and Week 6 | Cariprazine 1.5 mg/Day + ADT | -13.8 score on a scale (±0.69 Standard Error) |
| Cariprazine 3 mg/Day + ADT | -14.8 score on a scale (±0.70 Standard Error) | |||
| Placebo + ADT | -13.4 score on a scale (±0.70 Standard Error) | |||
| NCT05368558 509 JPN Schz | Schizophrenia | Change in SCI-PANSS Total Score From Baseline (Wk 0) to Week 6. Baseline (Wk 0) to Week 6 | DBP Cariprazine 3 mg | -5.6 score on a scale (±10.38 Standard Deviation) |
| DBP Cariprazine 6 mg | -30.2 score on a scale (±17.47 Standard Deviation) | |||
| DBP Placebo | -15.2 score on a scale (±12.21 Standard Deviation) | |||
| NCT05368558 509 JPN Schz | Schizophrenia | Number of Participants With Treatment Emergent Adverse Events (TEAEs) From first dose of study drug until 8 weeks following last dose of study drug (up to 32 weeks) | DBP Cariprazine 3 mg | 2 Participants |
| DBP Cariprazine 6 mg | 10 Participants | |||
| DBP Placebo | 12 Participants |