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: NCT03738215
• Other study ID #: 3111-301-001
• Secondary ID: 2018-002782-19
• Status: Completed
• Phase: Phase 3
• Start date: November 9, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: September 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: 759
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 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]).

• Patient must be an outpatient at the time of Visit 1 (Screening).

• Patient meets the DSM-5 criteria for MDD based on 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.

• Patient demonstrates ability to follow study instructions and likely to complete all required visits.

• Patient must have an inadequate response, as measured by the modified 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 patients must agree to continue taking the same ADT dosing regimen through completion of Visit 6/ET. Patients 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 patients 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.

• Patient 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

Locations

Country	Name	City	State
Bulgaria	State Psychiatry Hospital-Kardzhali; Third Male Department /ID# 234625	Kardzhali
Bulgaria	MHAT Dr. Hristo Stambolski EOOD; Hospital Pharmacy /ID# 234773	Kazanlak
Bulgaria	UMHAT Dr Georgi Stranski EAD /ID# 237828	Pleven
Bulgaria	Clinic of Psychiatry /ID# 235878	Plovdiv
Bulgaria	Medical Center Mentalcare OOD /ID# 234934	Plovdiv
Bulgaria	Mental health Centre-Ruse EOOD /ID# 234775	Ruse
Bulgaria	Medical Center Hera EOOD /ID# 235859	Sofia
Bulgaria	Medical Center Sveti Naum EOOD /ID# 236069	Sofia
Bulgaria	Medical complex Doverie /ID# 238307	Sofia
Bulgaria	UMHAT Alexandrovska EAD /ID# 237834	Sofiya	Sofia
Bulgaria	Medical Centre - VAS OOD /ID# 235719	Targovishte
Bulgaria	Diagnostic consultative center Mladost M /ID# 236253	Varna
Bulgaria	Diagnostic consultative center Mladost M /ID# 236254	Varna
Bulgaria	Mental Health Center - Veliko Tarnovo EOOD Veliko Tarnovo /ID# 236078	Veliko Tarnovo
Bulgaria	Mental Health Center - Vratsa EOOD Hospital Pharmacy /ID# 235960	Vratsa
Estonia	Marienthali Kliinik /ID# 235677	Tallinn
Estonia	West Tallinn Central Hospital /ID# 237078	Tallinn
Estonia	OU Jaanson and Laane /ID# 234985	Tartu
Estonia	Tartu University Hospital /ID# 237079	Tartu Linn	Tartumaa
Germany	Arztpraxis Dr Kirsten Hahn /ID# 235958	Berlin
Germany	BAG Prof. Dr. Kunte / Dr. sc. med. A. Schulze /ID# 235970	Berlin
Germany	Emovis GmbH /ID# 235010	Berlin
Germany	MVZ LIO Berlin /ID# 235711	Berlin
Germany	Private Practice - Dr. Thomsen /ID# 235713	Berlin
Germany	Klinikum Chemnitz gGmbH /ID# 237758	Chemnitz
Germany	Universitaetsklinikum Frankfurt /ID# 237292	Frankfurt am Main	Hessen
Germany	Studienzentrum Nord-West /ID# 236357	Westerstede
Hungary	Clinexpert Kft /ID# 237266	Budapest
Hungary	Jozsefvarosi Szent Kozma Egeszsegugyi Kozpont /ID# 235095	Budapest
Hungary	Nyiro Gyula Orszagos Pszichiatriai és Addiktologiai Intezet /ID# 235912	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft. /ID# 237495	Budapest	Pest
Hungary	Semmelweis Egyetem /ID# 237096	Budapest
Hungary	Varoskapu Rendelo - Processus Kft. /ID# 235170	Budapest
Hungary	Bugat Pal Korhaz /ID# 238145	Gyöngyös	Heves
Hungary	Bacs-Kiskun Megyei Oktatokorhaz Szent-Kereszt Korhaz /ID# 235974	Kalocsa	Bacs-Kiskun
Hungary	PsychoTech Kft. /ID# 235008	Pecs	Baranya
Hungary	Szent Borbala Korhaz /ID# 238293	Tatabanya	Komarom-Esztergom
Ukraine	KNP Prykarpatskyi Regional Clinical Centre of Mental Health /ID# 234999	Ivano-Frankivsk	Ivano-Frankivska Oblast
Ukraine	SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236336	Kharkiv	Kharkivska Oblast
Ukraine	SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236338	Kharkiv	Kharkivska Oblast
Ukraine	SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236340	Kharkiv	Kharkivska Oblast
Ukraine	Geikivka multidisciplinary hospital for psychiatric care /ID# 234498	Kryvbas Village	Dnipropetrovska Oblast
Ukraine	KNP Kyiv City Psychoneurological Hospital /ID# 235093	Kyiv
Ukraine	Kyiv Railway Clinical Hosp No.2 /ID# 237405	Kyiv
Ukraine	CNE of LOR Lviv Regional Clinical Psychiatric Hospital /ID# 236270	Lviv
Ukraine	MNCE Odesa Regional Medical Center for Mental Health /ID# 235723	Odesa
Ukraine	Odesa regional psychiatric hospital 2 of the ORC /ID# 234505	Oleksandrivka Village	Odeska Oblast
Ukraine	Cherkasy regional psychiatric hospital of the CRC /ID# 234513	Smila	Cherkaska Oblast
Ukraine	Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 234509	Stepanivka Village	Khersonska Oblast
Ukraine	Ternopil University Hospital /ID# 236819	Ternopil
Ukraine	KNP Zakarpatskyi Regional MC of Mental Health and Medicine of Dependencies /ID# 234499	Uzhgorod	Zakarpatska Oblast
Ukraine	Vinnytsia Regional Psycho-Neurological Hospital /ID# 235178	Vinnytsia
Ukraine	Vinnytsia Regional Psycho-Neurological Hospital /ID# 235179	Vinnytsia
United Kingdom	MAC Clinical Research /ID# 235938	Blackpool
United Kingdom	MAC Clinical Research /ID# 235941	Blackpool
United Kingdom	MAC Clinical Research /ID# 235945	Blackpool
United Kingdom	MAC Clinical Research /ID# 239078	Blackpool
United Kingdom	St. Peter's Hospital Surrey and Borders Partnership NHS FT /ID# 235725	Chertsey	Surrey
United Kingdom	MAC Clinical Research-Manchester /ID# 235940	Manchester
United Kingdom	Knowle House Surgery /ID# 235025	Plymouth	Devon
United States	Lehigh Center for Clinical Research /ID# 236702	Allentown	Pennsylvania
United States	Institute for Advanced Medical Research /ID# 236672	Alpharetta	Georgia
United States	Advanced Research Center /ID# 237957	Anaheim	California
United States	California Pharmaceutical Research Institute /ID# 236732	Anaheim	California
United States	Michigan Clinical Research Institute /ID# 234792	Ann Arbor	Michigan
United States	Austin Clinical Trial Partners /ID# 236551	Austin	Texas
United States	BioBehavioral Research of Austin /ID# 236477	Austin	Texas
United States	Quest Therapeutics of Avon Lake /ID# 236282	Avon Lake	Ohio
United States	Pharmasite Research, Inc. /ID# 237395	Baltimore	Maryland
United States	Houston Clinical Trials /ID# 234442	Bellaire	Texas
United States	Northwest Clinical Research Center /ID# 237584	Bellevue	Washington
United States	Hassman Research Institute /ID# 237501	Berlin	New Jersey
United States	NeuroBehavioral Medicine Group /ID# 236671	Bloomfield Hills	Michigan
United States	Integrative Clinical Trials /ID# 236656	Brooklyn	New York
United States	New Hope Clinical Research Inc. /ID# 234557	Charlotte	North Carolina
United States	CTI Clinical Trial and Consulting /ID# 236271	Cincinnati	Ohio
United States	Olympian Clinical Research /ID# 237417	Clearwater	Florida
United States	Axiom Research /ID# 236268	Colton	California
United States	The Ohio State University Department of Psychiatry /ID# 234583	Columbus	Ohio
United States	ATP Clinical Research, Inc /ID# 236619	Costa Mesa	California
United States	ProScience Research Group /ID# 236442	Culver City	California
United States	FutureSearch Trials of Dallas, LP /ID# 236275	Dallas	Texas
United States	iResearch Atlanta, LLC /ID# 237389	Decatur	Georgia
United States	Core Clinical Research /ID# 236405	Everett	Washington
United States	Precise Research Centers /ID# 236598	Flowood	Mississippi
United States	Psychiatric Consultants PC /ID# 235839	Franklin	Tennessee
United States	Earle Research /ID# 236661	Friendswood	Texas
United States	CBH Health LLC /ID# 234536	Gaithersburg	Maryland
United States	Collaborative Neuroscience Research - Orange County /ID# 237639	Garden Grove	California
United States	MD Clinical	Hallandale Beach	Florida
United States	Reliable Clinical Research /ID# 234786	Hialeah	Florida
United States	Red Oak Psychiatry Associates /ID# 236600	Houston	Texas
United States	Irvine Clinical Research /ID# 237409	Irvine	California
United States	CNS Healthcare - Jacksonville /ID# 238241	Jacksonville	Florida
United States	Omega Clinical Trials LLC /ID# 238168	La Habra	California
United States	Lake Charles Clinical Trials /ID# 237723	Lake Charles	Louisiana
United States	Altea Research Institute /ID# 236726	Las Vegas	Nevada
United States	Synergy San Diego /ID# 236654	Lemon Grove	California
United States	Capstone Clinical Research /ID# 236546	Libertyville	Illinois
United States	Alivation Research /ID# 236583	Lincoln	Nebraska
United States	Pillar Clinical Research /ID# 235702	Lincolnwood	Illinois
United States	Atria Clinical Research /ID# 237988	Little Rock	Arkansas
United States	Psych Atlanta /ID# 235835	Marietta	Georgia
United States	Clinical Neuroscience Solutions - Memphis /ID# 237476	Memphis	Tennessee
United States	Manhattan Behavioral Medicine PLLC /ID# 236314	New York	New York
United States	Coastal Carolina Research Center /ID# 235909	North Charleston	South Carolina
United States	IPS Research Company /ID# 237671	Oklahoma City	Oklahoma
United States	Sooner Clinical Research /ID# 236346	Oklahoma City	Oklahoma
United States	Space Coast Neuropsychiatric Research Institute /ID# 235765	Palm Bay	Florida
United States	Alea Research /ID# 234789	Phoenix	Arizona
United States	AIM Trials /ID# 236369	Plano	Texas
United States	Oregon Center for Clinical Investigations, Inc. - Portland /ID# 236649	Portland	Oregon
United States	Richard Weisler MD, PA & Assoc /ID# 237424	Raleigh	North Carolina
United States	Anderson Clinical Research /ID# 236627	Redlands	California
United States	Pillar Clinical Research LLC /ID# 234465	Richardson	Texas
United States	Finger Lakes Clinical Research /ID# 236578	Rochester	New York
United States	Woodland Research Northwest, LLC /ID# 236641	Rogers	Arkansas
United States	Millennium Psychiatric Associates LLC /ID# 235989	Saint Louis	Missouri
United States	Sharp Mesa Vista Hospital /ID# 235797	San Diego	California
United States	J. Gary Booker MD APMC /ID# 234514	Shreveport	Louisiana
United States	University of South Florida /ID# 234386	Tampa	Florida
United States	Viking Clinical Research /ID# 236614	Temecula	California
United States	CincyScience /ID# 236391	West Chester	Ohio
United States	NeuroPsychiatric Research Practice & Associate LTD /ID# 234636	Winfield	Illinois
United States	Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 236087	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Bulgaria,  Estonia,  Germany,  Hungary,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Score Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale)	The MADRS is a 10-item, clinician-rated scale that evaluates the patient's depressive symptomatology during the past week. Patients are 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 is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. mITT Population included all randomized participants who had =1 postbaseline assessment of the MADRS total score. Number of subjects analyzed are the number of participants with data available 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 scores indicate worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analyses. mITT Population included all randomized participants who had =1 postbaseline assessment of the MADRS total score. Number of subjects analyzed are the number of participants with data available for analyses.	Baseline and Week 6