A Phase 3 interventional study of Cariprazine and Placebo in Major Depressive Disorder, sponsored by AbbVie. Completed at 112 sites in 8 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-09-21.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to antidepressants alone.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's enrollment of 752 is above the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →AbbVie is the lead sponsor of 967 studies on the registry; 132 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
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Exclusion Criteria:
Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing antidepressant therapy (ADT) \[same antidepressant and dose of ADT they were on at the Baseline\] during the Double-blind Treatment Period, up to Week 6.
Drug: Placebo · Drug: Antidepressant Therapy (ADT)
Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.
Drug: Cariprazine · Drug: Antidepressant Therapy (ADT)
Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.
Drug: Cariprazine · Drug: Antidepressant Therapy (ADT)
Cariprazine supplied in capsules
Also known as: VRAYLAR®
Placebo supplied in capsules
ADT as prescribed by the physician per standard of care in clinical practice.
Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score
The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change from Baseline indicates improvement. Mixed-effects Model for Repeated Measures (MMRM) was used for analyses.
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in the Clinical Global Impressions-Severity (CGI-S) Score
The CGI-S is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1=normal, not at all ill and 7=among the most extremely ill participants. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analyses.
Time frame: Baseline and Week 6
| Milestone | Placebo + ADT | Cariprazine 1.5 mg/Day + ADT | Cariprazine 3 mg/Day + ADT |
|---|---|---|---|
| Started | 250 | 250 | 251 |
| Modified intent-to treat (mitt) population | 249 | 250 | 251 |
| Completed | 235 | 233 | 226 |
| Not completed | 15 | 17 | 25 |
| Withdrew: Adverse event | 6 | 9 | 13 |
| Withdrew: Lack of efficacy | 1 | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 | 2 |
| Withdrew: Withdrawal by subject | 4 | 4 | 6 |
| Withdrew: Protocol deviation | 1 | 0 | 1 |
| Withdrew: Non-compliance with study drug | 1 | 3 | 1 |
| Withdrew: Reason not specified | 1 | 0 | 1 |
| Milestone | Placebo + ADT | Cariprazine 1.5 mg/Day + ADT | Cariprazine 3 mg/Day + ADT |
|---|---|---|---|
| Started | 242 | 242 | 242 |
| Completed | 240 | 240 | 238 |
| Not completed | 2 | 2 | 4 |
| Withdrew: Withdrawal by subject | 1 | 2 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 2 |
| Withdrew: Death | 1 | 0 | 0 |
| Withdrew: Reason not specified | 0 | 0 | 2 |
The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change from Baseline indicates improvement. Mixed-effects Model for Repeated Measures (MMRM) was used for analyses.
| score on a scale | Placebo + ADT | Cariprazine 1.5 mg/Day + ADT | Cariprazine 3 mg/Day + ADT |
|---|---|---|---|
| Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score | -13.4 ± 0.70 | -13.8 ± 0.69 | -14.8 ± 0.70 |
The CGI-S is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1=normal, not at all ill and 7=among the most extremely ill participants. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analyses.
| score on a scale | Placebo + ADT | Cariprazine 1.5 mg/Day + ADT | Cariprazine 3 mg/Day + ADT |
|---|---|---|---|
| Change From Baseline to Week 6 in the Clinical Global Impressions-Severity (CGI-S) Score | -1.4 ± 0.09 | -1.4 ± 0.09 | -1.6 ± 0.09 |
Collected over First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo + ADT | 1/250 (0.4%) | 2/250 (0.8%) | 54/250 (21.6%) |
| Cariprazine 1.5 mg/Day + ADT | 0/250 (0%) | 3/250 (1.2%) | 70/250 (28%) |
| Cariprazine 3 mg/Day + ADT | 0/251 (0%) | 1/251 (0.4%) | 85/251 (33.9%) |
| Event | Placebo + ADT | Cariprazine 1.5 mg/Day + ADT | Cariprazine 3 mg/Day + ADT |
|---|---|---|---|
| INTESTINAL OBSTRUCTIONGastrointestinal disorders | 1/250 | 0/250 | 0/251 |
| DEATHGeneral disorders | 1/250 | 0/250 | 0/251 |
| ANIMAL BITEInjury, poisoning and procedural complications | 0/250 | 1/250 | 0/251 |
| FALLInjury, poisoning and procedural complications | 0/250 | 1/250 | 0/251 |
| FIBULA FRACTUREInjury, poisoning and procedural complications | 0/250 | 1/250 | 0/251 |
| LIGAMENT SPRAINInjury, poisoning and procedural complications | 0/250 | 1/250 | 0/251 |
| SUICIDE ATTEMPTPsychiatric disorders | 0/250 | 1/250 | 0/251 |
| ATRIAL FIBRILLATIONCardiac disorders | 0/250 | 0/250 | 1/251 |
| Event | Placebo + ADT | Cariprazine 1.5 mg/Day + ADT | Cariprazine 3 mg/Day + ADT |
|---|---|---|---|
| AKATHISIANervous system disorders | 9/250 | 19/250 | 29/251 |
| HEADACHENervous system disorders | 27/250 | 24/250 | 27/251 |
| INSOMNIAPsychiatric disorders | 9/250 | 16/250 | 25/251 |
| SOMNOLENCENervous system disorders | 11/250 | 12/250 | 17/251 |
| NAUSEAGastrointestinal disorders | 10/250 | 14/250 | 16/251 |
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
| Age, Continuous(years) | Placebo + ADT | Cariprazine 1.5 mg/Day + ADT | Cariprazine 3 mg/Day + ADT | Total |
|---|---|---|---|---|
| Mean | 46.2 ± 12.12 | 45.0 ± 12.95 | 45.8 ± 12.45 | 45.7 ± 12.51 |
| Sex: Female, Male(Participants) | Placebo + ADT | Cariprazine 1.5 mg/Day + ADT | Cariprazine 3 mg/Day + ADT | Total |
|---|---|---|---|---|
| Female | 191 | 185 | 197 | 573 |
| Male | 59 | 65 | 54 | 178 |
| Ethnicity (NIH/OMB)(Participants) | Placebo + ADT | Cariprazine 1.5 mg/Day + ADT | Cariprazine 3 mg/Day + ADT | Total |
|---|---|---|---|---|
| Hispanic or Latino | 30 | 38 | 34 | 102 |
| Not Hispanic or Latino | 220 | 212 | 217 | 649 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo + ADT | Cariprazine 1.5 mg/Day + ADT | Cariprazine 3 mg/Day + ADT | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 2 | 2 |
| Asian | 4 | 0 | 5 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 29 | 32 | 22 | 83 |
| White | 217 | 216 | 221 | 654 |
| More than one race | 0 | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(score on a scale) | Placebo + ADT | Cariprazine 1.5 mg/Day + ADT | Cariprazine 3 mg/Day + ADT | Total |
|---|---|---|---|---|
| Mean | 32.99 ± 4.789 | 32.00 ± 4.246 | 32.25 ± 4.688 | 32.41 ± 4.593 |
| Clinical Global Impression-Severity (CGI-S) Scale Score(score on a scale) | Placebo + ADT | Cariprazine 1.5 mg/Day + ADT | Cariprazine 3 mg/Day + ADT | Total |
|---|---|---|---|---|
| Mean | 4.67 ± 0.599 | 4.61 ± 0.586 | 4.65 ± 0.654 | 4.64 ± 0.614 |
Showing the first 100 of 112 sites across 8 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: For details on when studies are available for sharing, please refer to the link below
Access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Data sharing details ↗ · vivli.org
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cariprazine