drugset / Trial / NCT01715805
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
RandomizedParallel-groupTriple-blindTreatment
Summary
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
Timeline
- Start
- 2012-11-15
- Primary completion
- 2016-06-24
- Completion
- 2016-06-24
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo + ADT (Double-Blind) vs Cariprazine + ADT (Double-Blind); p = 0.7948; Least Squares Mean Difference (LSMD) -0.2 (95% CI -1.6 to 1.2); NCT01715805 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cariprazine | Small molecule | 1.5 mg | Oral |
| Subject | Cariprazine | Small molecule | 4.5 mg | Oral |
| Background | Bupropion | Small molecule | — | — |
| Background | Citalopram | Small molecule | — | — |
| Background | Desvenlafaxine | Other / unclassified | — | — |
| Background | Duloxetine | Small molecule | — | — |
| Background | Escitalopram | Small molecule | — | — |
| Background | Fluoxetine | Small molecule | — | — |
| Background | Paroxetine | Small molecule | — | — |
| Background | Sertraline | Small molecule | — | — |
| Background | Venlafaxine | Small molecule | — | — |
| Background | Vilazodone | Small molecule | — | — |