Phase 2
Completed N=231
Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder
Source: ClinicalTrials.gov NCT00854100 ↗Enrolled (actual)
231
Serious AEs
1.5%
Results posted
Mar 2019
Primary outcomePrimary: Montgomery-Asberg Depression Rating Scale (MADRS) — -8.0; -7.5; -9.8 Units on a Scale — p=0.746
Summary
This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery-Asberg Depression Rating Scale (MADRS) |
-8.0; -7.5; -9.8 | 0.746 |
| SECONDARY Clinical Global Impression - Improvement (CGI-I) |
2.5; 2.5; 2.3 | 0.918 |
Eligibility Criteria
Inclusion Criteria
- Men and women, 18-65 years old
- Currently meet the DSM-IV-TR criteria for moderate to severe MDD without psychotic features.
- Previous failure to respond to adequate trials of one or two ADTs with less than 50% reduction in depressive symptoms during the present episode.
Exclusion Criteria
- DSM-IV-TR based diagnosis of an axis I disorder, other than MDD, or any axis I disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
Data sourced from ClinicalTrials.gov (NCT00854100). 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.