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

Major Depressive Disorder Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to Antidepressants Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03739203
• Other study ID #: 3111-302-001
• Secondary ID: 2018-003164-31
• Status: Completed
• Phase: Phase 3
• Start date: November 10, 2018
• Est. completion date: September 6, 2021

Study information

• Verified date: August 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 752
• Est. completion date: September 6, 2021
• Est. primary completion date: September 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Cariprazine
Cariprazine supplied in capsules
• Placebo
Placebo supplied in capsules
• Antidepressant Therapy (ADT)
ADT as prescribed by the physician per standard of care in clinical practice.

Locations

Country	Name	City	State
Canada	Chatham-Kent Clinical Trials /ID# 235707	Chatham	Ontario
Canada	Introspect Clinical Research Centre /ID# 235987	Ottawa	Ontario
Canada	Recherches Neuro-Hippocampe Inc. d/b/a Ottawa Memory Clinic /ID# 235890	Ottawa	Ontario
Canada	Diex Recherche Sherbrooke Inc. /ID# 234385	Sherbrooke	Quebec
Czechia	MUDr. Marta Holanova /ID# 235126	Brno
Czechia	Saint Anne s.r.o. /ID# 235060	Brno
Czechia	Neuropsychiatriehk s.r.o. /ID# 236195	Hradec Kralove
Czechia	A-SHINE s.r.o. /ID# 236370	Plzen
Czechia	CLINTRIAL s.r.o. /ID# 237794	Prague 10
Czechia	INEP medical s.r.o. /ID# 236291	Praha
Czechia	Medical Services Prague /ID# 235109	Praha 6	Praha, Hlavni Mesto
Finland	Helsingin psykiatripalvelu /ID# 235090	Helsinki
Finland	Mederon Oy /ID# 235057	Helsinki
Finland	Savon Psykiatripalvelu Oy /ID# 235028	Kuopio
Finland	Oulu Mentalcare Oy /ID# 235089	Oulu
Finland	Satakunnan Psykiatripalvelu Oy /ID# 234936	Rauma
Finland	Psykiatri- ja psykologikeskus Mentoria /ID# 235091	Tampere
Poland	Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski /ID# 234851	Belchatow	Lodzkie
Poland	Wlokiennicza Med /ID# 235105	Bia?ystok
Poland	MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk /ID# 235065	Bialystok
Poland	Med-Art /Id# 234986	Bydgoszcz
Poland	Przychodnia Srodmiescie Sp. Z o.o. /ID# 236197	Bydgoszcz
Poland	Poradnia Zdrowia Psychicznego /ID# 234750	Chelmno
Poland	Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 237466	Gdansk	Pomorskie
Poland	Centrum Zdrowia Psychicznego BioMed - Jan Latala /ID# 235064	Kielce
Poland	Nzop Mentis /Id# 235062	Leszno
Poland	Centrum Medyczne Luxmed /ID# 235110	Lublin	Lubelskie
Poland	Centrum Medyczne Neuromedica /ID# 235615	Lublin
Poland	Krzysztof Klinke Prywatny Gabinet Psychiatryczny /ID# 235061	Sosnowiec
Poland	Zachodniopomorski Instytut Psychoterapii /ID# 236549	Szczecin	Zachodniopomorskie
Poland	Gabinet Lekarski Torunskie Centrum Psychiatrii Neuromed /ID# 235001	Torun
Poland	Osrodek Badan Klinicznych Clinsante /ID# 234990	Torun
Poland	Przychodnia Lekarsko-Psychologiczna PERSONA /ID# 235007	Wroclaw
Puerto Rico	INSPIRA Clinical Research /ID# 234542	San Juan
Serbia	Bel Medic - General Hospital /ID# 236171	Belgrade
Serbia	Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 234299	Belgrade
Serbia	Institute of Mental Health /ID# 236481	Belgrade
Serbia	Military Medical Academy /ID# 237062	Belgrade	Beograd
Serbia	University Clinical Center Serbia /ID# 237747	Belgrade	Beograd
Serbia	Special Hospital for Psychiatric Diseases Kovin /ID# 234691	Kovin
Serbia	University Clinical Center Kragujevac /ID# 237750	Kragujevac	Sumadijski Okrug
Serbia	University Clinical Center Kragujevac /ID# 237752	Kragujevac	Sumadijski Okrug
Serbia	University Clinical Center Kragujevac /ID# 237753	Kragujevac	Sumadijski Okrug
Serbia	University Clinical Center of Nis /ID# 236973	NIS	Nisavski Okrug
Serbia	Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 234716	Novi Knezevac
Serbia	Special Psychiatric Hospital /ID# 235152	Vršac
Slovakia	J&J SMART Ltd. /ID# 235902	Bratislava
Slovakia	Psychiatrická ambulancia MENTUM /ID# 235020	Bratislava
Slovakia	Vavrusova Consulting s.r.o. /ID# 235022	Bratislava
Slovakia	EPAMED s.r.o. /ID# 234830	Kosice
Slovakia	Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas /ID# 235216	Liptovsky Mikulas
Slovakia	Psycholine s.r.o /ID# 235081	Rimavska Sobota
Slovakia	Centrum zdravia R.B.K sro /ID# 235085	Svidnik
Slovakia	Crystal Comfort s.r.o. /ID# 235083	Vranov nad Toplou
United States	California Pharmaceutical Research Institute /ID# 236731	Anaheim	California
United States	Atlanta Center for Medical Research /ID# 234696	Atlanta	Georgia
United States	Institute for Advanced Medical Research /ID# 234992	Atlanta	Georgia
United States	Quest Therapeutics of Avon Lake /ID# 236281	Avon Lake	Ohio
United States	Boston Clinical Trials /ID# 236558	Boston	Massachusetts
United States	SPRI Clinical Trails /ID# 236657	Brooklyn	New York
United States	Center for Emotional Fitness /ID# 236630	Cherry Hill	New Jersey
United States	Patient Priority Clinical Sites, LLC /ID# 236743	Cincinnati	Ohio
United States	MCB Clinical Research Centers /ID# 236927	Colorado Springs	Colorado
United States	Axiom Research /ID# 236267	Colton	California
United States	Global Clinical Trials /ID# 235059	Costa Mesa	California
United States	CT Clinical Research /ID# 234638	Cromwell	Connecticut
United States	Harmonex /ID# 236936	Dothan	Alabama
United States	Innovative Clinical Research /ID# 235186	Fort Lauderdale	Florida
United States	Gulfcoast Clinical Research Center /ID# 236280	Fort Myers	Florida
United States	Psychiatric Consultants PC /ID# 235838	Franklin	Tennessee
United States	Earle Research /ID# 236660	Friendswood	Texas
United States	Collaborative Neuroscience Research - Orange County /ID# 237637	Garden Grove	California
United States	Behavioral Research Specialists, LLC /ID# 236622	Glendale	California
United States	Clinical Trials America /ID# 237636	Hickory	North Carolina
United States	Sun Valley Research Center /ID# 236560	Imperial	California
United States	Woodland International Research Group /ID# 236349	Little Rock	Arkansas
United States	SSM Health Dean Medical Group /ID# 238103	Madison	Wisconsin
United States	Research Strategies of Memphis /ID# 236629	Memphis	Tennessee
United States	Innova Clinical Trials /ID# 237376	Miami	Florida
United States	International Research Associates, LLC /ID# 237410	Miami	Florida
United States	North Star Medical Research LL /ID# 235076	Middleburg Heights	Ohio
United States	Bioscience Research /ID# 234961	Mount Kisco	New York
United States	AMR Conventions Research /ID# 236262	Naperville	Illinois
United States	BTC of New Bedford /ID# 236381	New Bedford	Massachusetts
United States	Eastside Comprehensive Medical Center LLC /ID# 236094	New York	New York
United States	Fieve Clinical Research, Inc. /ID# 236632	New York	New York
United States	Excell Research, Inc /ID# 237717	Oceanside	California
United States	North County Clinical Research /ID# 235014	Oceanside	California
United States	Lynn Health Science Institute (LHSI) /ID# 237612	Oklahoma City	Oklahoma
United States	NRC Research Institute /ID# 234632	Orange	California
United States	Medical Research Group of Central Florida /ID# 237326	Orange City	Florida
United States	Clinical Neuroscience Solutions, Inc /ID# 236604	Orlando	Florida
United States	Space Coast Neuropsychiatric Research Institute /ID# 235766	Palm Bay	Florida
United States	AIM Trials /ID# 236366	Plano	Texas
United States	Keystone Clinical Studies LLC /ID# 238153	Plymouth Meeting	Pennsylvania
United States	Collective Medical Research /ID# 236397	Prairie Village	Kansas
United States	Anderson Clinical Research /ID# 236624	Redlands	California
United States	Oregon Ctr for Clin Inv /ID# 237463	Salem	Oregon
United States	Clinical Trials of Texas, Inc /ID# 237864	San Antonio	Texas
United States	Syrentis Clinical Research /ID# 237408	Santa Ana	California
United States	iResearch Savannah /ID# 236082	Savannah	Georgia
United States	California Neuroscience Research Medical Group, Inc. /ID# 236636	Sherman Oaks	California
United States	Schuster Medical Research Institute /ID# 236445	Sherman Oaks	California
United States	Iris Research Inc. /ID# 234995	Smyrna	Georgia
United States	The Coastal Research Associates Inc /ID# 235056	South Weymouth	Massachusetts
United States	Sisu at Renaissance Medical Group /ID# 236198	Springfield	Massachusetts
United States	Family Psychiatry of The Woodlands /ID# 236423	The Woodlands	Texas
United States	Bio Behavioral Health, Inc /ID# 238209	Toms River	New Jersey
United States	Central States Research /ID# 238295	Tulsa	Oklahoma
United States	Pacific Clinical Research Management Group /ID# 234378	Upland	California
United States	CincyScience /ID# 236387	West Chester	Ohio
United States	Woodstock Research Center /ID# 236653	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Finland,  Poland,  Puerto Rico,  Serbia,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score	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.	Baseline and Week 6
Secondary	Change From Baseline to Week 6 in the Clinical Global Impressions-Severity (CGI-S) Score	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.	Baseline and Week 6

External Links

•   VRAYLAR® (cariprazine) capsules prescribing information.