Phase 2 Completed N=819 Randomized Quadruple-blind Treatment

Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder

Major Depressive Disorder

Source: ClinicalTrials.gov NCT01469377 ↗

Enrolled (actual)

819

Serious AEs

0.5%

Results posted

May 2018

Primary outcomePrimary: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8 — -12.5; -13.4; -14.6 Units on a scale — p=0.2404

Summary

An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study consisted of approximately 2 weeks of screening and washout followed by 8 weeks of double-blind treatment followed by a 1 week safety follow-up.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8	-12.5; -13.4; -14.6	0.2404
SECONDARY Change From Baseline in the Sheehan Disability Scale (SDS) Total Score at Week 8	-6.6; -7.7; -8.0	0.2404

Eligibility Criteria

Inclusion Criteria

Male or female outpatients 18 to 65 years of age, inclusive.
Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive disorder (MDD).
Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration.
Ongoing inadequate response to protocol allowed antidepressant therapy (ADT).

Exclusion Criteria

Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,
Women who are pregnant, or planning to become pregnant or breastfeed during the study or not practicing reliable contraception that will continue through out the study.
History of meeting DSM-IV-TR criteria for:
Depressive episode with psychotic or catatonic features.
Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode.
Schizophrenia, schizoaffective, or other psychotic disorder.
Obsessive-compulsive disorder.
Bulimia or anorexia nervosa.
Dementia, amnesic, or other cognitive disorder.
Mental retardation.
Participants considered a suicide risk.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01469377). 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.