Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
NCT03593213Phase 3Terminated
- Lead sponsor
- AbbVie (Industry)
- Enrollment
- 587 (actual)
- Start date
- 30 Jul 2018
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021
- Last update posted
- 11 Apr 2022
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Double
- Arms
- 4
Interventions
- Cariprazine Drug
- Placebo Drug
Conditions and primary outcome
- Schizophrenia
Primary outcome
Time to First Relapse During Double-blind Treatment Period (Randomization (Week 18) to End of Treatment (Week 44))
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT03593213 (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
Time to First Relapse During Double-blind Treatment Period
- Time frame
- Randomization (Week 18) to End of Treatment (Week 44)
- Measure
- Median
- Unit
- days
Placebo (Double-blind Treatment Period) vs Cariprazine 3.0 mg/Day (Double-blind Treatment Period)Superiority
- Estimate
- 0.56Hazard Ratio (HR)
- 95% CI, two-sided
- 0.25 to 1.29
- p-value
- =0.1576
- Method
- Log Rank
Placebo (Double-blind Treatment Period) vs Cariprazine 4.5 mg/Day (Double-blind Treatment Period)Superiority
- Estimate
- 0.61Hazard Ratio (HR)
- 95% CI, two-sided
- 0.26 to 1.45
- p-value
- =0.2066
- Method
- Log Rank
Serious adverse events
Time frame: First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
| Group | Affected | At risk |
|---|---|---|
| Cariprazine 4.5 mg/Day (Open-label Treatment Period) | 20 | 587 |
| Cariprazine 4.5 mg/Day (Open-label Safety Follow-up) | 7 | 273 |
| Placebo (Double-blind Treatment Period) | 5 | 53 |
| Cariprazine 3.0 mg/Day (Double-blind Treatment Period) | 0 | 49 |
| Cariprazine 4.5 mg/Day (Double-blind Treatment Period) | 1 | 54 |
| Placebo (Double-blind Safety Follow-up) | 0 | 53 |
| Cariprazine 3.0 mg/Day (Double-blind Safety Follow-up) | 0 | 49 |
| Cariprazine 4.5 mg/Day (Double-blind Safety Follow-up) | 2 | 54 |
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
No PubMed citation lists NCT03593213.
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
- NCT03593213 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.