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 Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone

Phase 3

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Placebo
Drug: Cariprazine
Drug: Antidepressant Therapy (ADT)

Registration Number: NCT03739203

Lead Sponsor: AbbVie

Brief 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 who have had an inadequate response to antidepressants alone.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 752

Inclusion Criteria

Written informed consent has been obtained.
Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]).
Participant must be an outpatient at the time of Visit 1 (Screening).
Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD based on Structured Clinical Interview for DSM-5 (SCID-5), with a current major depressive episode of at least 8 weeks and not exceeding 24 months in duration at Visit 1/Screening. A diagnosis of MDD with psychotic features will be acceptable.
Diagnosis of MDD confirmed through a formal adjudication process.
Participant demonstrates ability to follow study instructions and likely to complete all required visits.
Participant must have an inadequate response, as measured by the modified antidepressant treatment response questionnaire (ATRQ), to 1 to 3 antidepressants administered during the current episode at an adequate dose (as per package insert) and for at least 6 weeks duration, with at least one dose escalation during the current depressive episode.
Only one antidepressant (of sufficient dose per package insert and taken for at least 6 weeks) will be allowed at randomization and Participants must agree to continue taking the same ADT dosing regimen through completion of Visit 6/early termination (ET). Participants who are taking more than one antidepressant at Screening, regardless of the indication, will need to discontinue all other antidepressants prior to Visit 2 (Baseline).
Male and female Participants must agree to use a medically acceptable and highly effective method of birth control during the course of the entire study.
Women of childbearing potential (only) must have a negative serum β-human chorionic gonadotropin pregnancy test prior to Visit 2.

Exclusion Criteria

Diagnosis of any current psychiatric diagnosis other than MDD (including those with current intellectual development disability) with the exception of specific phobias.
Participant has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + ADT	Placebo	Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing antidepressant therapy (ADT) \[same antidepressant and dose of ADT they were on at the Baseline\] during the Double-blind Treatment Period, up to Week 6.
Cariprazine 1.5 mg/day + ADT	Antidepressant Therapy (ADT)	Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.
Cariprazine 3 mg/day + ADT	Antidepressant Therapy (ADT)	Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.
Placebo + ADT	Antidepressant Therapy (ADT)	Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing antidepressant therapy (ADT) \[same antidepressant and dose of ADT they were on at the Baseline\] during the Double-blind Treatment Period, up to Week 6.
Cariprazine 3 mg/day + ADT	Cariprazine	Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.
Cariprazine 1.5 mg/day + ADT	Cariprazine	Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score	Baseline and Week 6	The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change from Baseline indicates improvement. Mixed-effects Model for Repeated Measures (MMRM) was used for analyses.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 6 in the Clinical Global Impressions-Severity (CGI-S) Score	Baseline and Week 6	The CGI-S is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1=normal, not at all ill and 7=among the most extremely ill participants. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analyses.

Trial Locations

Locations (112): Harmonex /ID# 236936
🇺🇸
Dothan, Alabama, United States
Woodland International Research Group /ID# 236349
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Little Rock, Arkansas, United States
California Pharmaceutical Research Institute /ID# 236731
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Anaheim, California, United States
Axiom Research /ID# 236267
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Colton, California, United States
Global Clinical Trials /ID# 235059
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Costa Mesa, California, United States
Collaborative Neuroscience Research - Orange County /ID# 237637
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Garden Grove, California, United States
Behavioral Research Specialists, LLC /ID# 236622
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Glendale, California, United States
Sun Valley Research Center /ID# 236560
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Imperial, California, United States
North County Clinical Research /ID# 235014
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Oceanside, California, United States
Excell Research, Inc /ID# 237717
🇺🇸
Oceanside, California, United States
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Harmonex /ID# 236936
🇺🇸Dothan, Alabama, United States