Phase 3
N=1,022
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01715805 ↗Enrolled (actual)
1,022
Serious AEs
0.8%
Results posted
Aug 2019
Primary outcome: Primary: Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period — 25.2; 25.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cariprazine (Drug); Placebo (Drug); Antidepressant Therapy (ADT) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period |
25.2; 25.4 | — |
| PRIMARY Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period |
-7.5; -7.7 | 0.7948 |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Score in the Double-Blind Period |
-3.1; -3.7 | 0.2784 |
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
Eligibility Criteria
Inclusion Criteria
- Patients who have provided consent prior to any specific procedure
- Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
- Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at Visits 1 and 2
Exclusion Criteria
- Patients who do not meet DSM-IV-TR criteria for MDD
Data sourced from ClinicalTrials.gov (NCT01715805). 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.