drugset / Trial / NCT03738215
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone
RandomizedParallel-groupDouble-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 who have had an inadequate response to antidepressants alone.
Timeline
- Start
- 2018-11-09
- Primary completion
- 2021-09-30
- Completion
- 2021-09-30
Publications
- Fava M, Masand PS, Maletic V, Chen C, Adams JL, Kerolous M. Efficacy of Adjunctive Cariprazine on Anxiety Symptoms in Patients With Major Depressive Disorder: Post Hoc Analysis of a Randomized Placebo-Controlled Trial. J Clin Psychiatry. 2025 Apr 30;86(2):24m15506. doi: 10.4088/JCP.24m15506.
- Sachs GS, Yeung PP, Rekeda L, Khan A, Adams JL, Fava M. Adjunctive Cariprazine for the Treatment of Patients With Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. Am J Psychiatry. 2023 Mar 1;180(3):241-251. doi: 10.1176/appi.ajp.20220504. Epub 2023 Feb 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cariprazine | Small molecule | 1.5 mg | Oral |
| Subject | Cariprazine | Small molecule | 3 mg | Oral |