Adults 18 to 65, any sex, with Depression, Bipolar. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6Primary· Baseline to Week 6
The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are 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 is 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 scores on the 10 items are summed for a total score that can range from 0 to 60. A higher score indicate
Group
Value
95% CI
Placebo
-11.1
± 0.9
Cariprazine 0.75 mg
-13.0
± 0.9
Cariprazine 1.5 mg
-15.1
± 0.8
Cariprazine 3.0 mg
-13.7
± 0.9
Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6Secondary· Baseline to Week 6
The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score indicates improvement.
Group
Value
95% CI
Placebo
-1.0
± 0.1
Cariprazine 0.75 mg
-1.1
± 0.1
Cariprazine 1.5 mg
-1.4
± 0.1
Cariprazine 3.0 mg
-1.3
± 0.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06433635 — Sequential Multiple Assignment Randomized Trial for Bipolar Depression
· Phase 4
· active not recruiting
NCT05913947 — Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
· Phase 4
· recruiting
NCT05368558 — Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Sc
· Phase 3
· terminated
NCT05384483 — Cariprazine Versus Placebo for Social Anxiety Disorder
· Phase 4
· completed
Other recruiting trials for Depression, Bipolar
Currently open trials in the same condition.
NCT06462196 — Natural History of Depression, Bipolar Disorder and Suicide Risk
· recruiting
NCT05913947 — Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
· Phase 4
· recruiting
NCT05767073 — LIVES: Personalized Lifestyle Intervention for Patients With Depression
· NA
· recruiting
NCT02788617 — Evaluation of the Efficacy of Diafert in Predicting Embryos' Potential to Develop to the Blastocyst Stage
· completed
NCT02732327 — Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer
· Phase 2
· terminated
NCT02670538 — Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode
· Phase 3
· completed
NCT02670551 — Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depres
· Phase 3
· completed
NCT02559570 — A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Forest Laboratories
Last refreshed: 1 May 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01396447.