Phase 3
Completed N=442
Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder
Source: ClinicalTrials.gov NCT01838876 ↗Enrolled (actual)
442
Serious AEs
2.0%
Results posted
Aug 2019
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period — 274 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The objective of this study is to evaluate the long-term safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period |
274 | — |
| PRIMARY Number of Participants With Newly Emergent Adverse Events (NEAEs) in the Safety Follow-up Period |
20 | — |
| PRIMARY Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters |
— | — |
| PRIMARY Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters |
— | — |
| PRIMARY Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG) |
1 | — |
| PRIMARY Number of Participants With Extrapyramidal Symptom (EPS)-Related TEAEs |
98 | — |
| PRIMARY Number of Participants in the Most Severe Suicidal Ideation and Suicidal Behavior Recorded on the C-SSRS During the Treatment Period |
308; 37; 1; 0; 6; 3 | — |
| PRIMARY Number of Participants With Treatment-Emergent Ocular Events |
1 | — |
| PRIMARY Change From Baseline in the Arizona Sexual Experiences Scale (ASEX) Score |
20.1; 17.2; -0.9; -0.1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have provided consent prior to any study specific procedures
- Meets the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for MDD
- New patients must have ongoing inadequate response to protocol allowed ADTs as reported in Antidepressant Treatment Response Questionnaire (ATRQ)
- For rollover patients from RGH-MD-72 [NCT01715805], completion of Study RGH-MD-72 (either double-blind or single-blind treatment periods) with continued ADT treatment.
Exclusion Criteria
- Patients who do not meet the DSM-IV-TR criteria for MDD.
Data sourced from ClinicalTrials.gov (NCT01838876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.