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
NCT03738215Phase 3Completed
- Lead sponsor
- AbbVie (Industry)
- Enrollment
- 759 (actual)
- Start date
- 9 Nov 2018
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021
- Last update posted
- 25 Oct 2022
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Double
- Arms
- 3
Interventions
- Cariprazine Drug
- Placebo Drug
Conditions and primary outcome
- Major Depressive Disorder
Primary outcome
Total Score Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) (Baseline and Week 6)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT03738215 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
Total Score Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale)
- Time frame
- Baseline and Week 6
- Measure
- Least squares mean
- Unit
- score on a scale
Placebo + ADT vs Cariprazine 1.5 mg/Day + ADTSuperiority
- Estimate
- -2.5Least Squares Mean Difference
- 95% CI, two-sided
- -4.17 to -0.89
- p-value
- 0.0050
- Method
- MMRM
Placebo + ADT vs Cariprazine 3 mg/Day + ADTSuperiority
- Estimate
- -1.5Least Squares Mean Difference
- 95% CI, two-sided
- -3.16 to 0.12
- p-value
- 0.0727
- Method
- MMRM
Serious adverse events
Time frame: First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
| Group | Affected | At risk |
|---|---|---|
| Placebo + ADT | 2 | 253 |
| Cariprazine 1.5 mg/Day + ADT | 3 | 252 |
| Cariprazine 3 mg/Day + ADT | 3 | 252 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
2 on PubMedEfficacy of Adjunctive Cariprazine on Anxiety Symptoms in Patients With Major Depressive Disorder: Post Hoc Analysis of a Randomized Placebo-Controlled Trial.
The Journal of clinical psychiatry · 2025 Apr 30
PubMed 40315101 (opens in a new tab)DOI 10.4088/JCP.24m15506 (opens in a new tab)
Adjunctive Cariprazine for the Treatment of Patients With Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study.
The American journal of psychiatry · 2023 Mar 1
PubMed 36789515 (opens in a new tab)DOI 10.1176/appi.ajp.20220504 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT03738215 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.