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

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT03738215

Run by

AbbVie

People needed

759

Starts

2018-11-09

Expected to finish

2021-09-30

Last updated by the study team

2022-10-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 β-human chorionic gonadotropin pregnancy test prior to Visit 2.

You may not qualify if…

• 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.

Where it is running

• Atria Clinical Research /ID# 237988 — Little Rock, Arkansas, United States
• Woodland Research Northwest, LLC /ID# 236641 — Rogers, Arkansas, United States
• California Pharmaceutical Research Institute /ID# 236732 — Anaheim, California, United States
• Advanced Research Center /ID# 237957 — Anaheim, California, United States
• Axiom Research /ID# 236268 — Colton, California, United States
• ATP Clinical Research, Inc /ID# 236619 — Costa Mesa, California, United States
• ProScience Research Group /ID# 236442 — Culver City, California, United States
• Collaborative Neuroscience Research - Orange County /ID# 237639 — Garden Grove, California, United States
• Irvine Clinical Research /ID# 237409 — Irvine, California, United States
• Omega Clinical Trials LLC /ID# 238168 — La Habra, California, United States
• Synergy San Diego /ID# 236654 — Lemon Grove, California, United States
• Anderson Clinical Research /ID# 236627 — Redlands, California, United States
• Sharp Mesa Vista Hospital /ID# 235797 — San Diego, California, United States
• Viking Clinical Research /ID# 236614 — Temecula, California, United States
• Olympian Clinical Research /ID# 237417 — Clearwater, Florida, United States
• MD Clinical — Hallandale, Florida, United States
• Reliable Clinical Research /ID# 234786 — Hialeah, Florida, United States
• CNS Healthcare - Jacksonville /ID# 238241 — Jacksonville, Florida, United States
• Space Coast Neuropsychiatric Research Institute /ID# 235765 — Palm Bay, Florida, United States
• University of South Florida /ID# 234386 — Tampa, Florida, United States
• Institute for Advanced Medical Research /ID# 236672 — Alpharetta, Georgia, United States
• iResearch Atlanta, LLC /ID# 237389 — Decatur, Georgia, United States
• Psych Atlanta /ID# 235835 — Marietta, Georgia, United States
• Capstone Clinical Research /ID# 236546 — Libertyville, Illinois, United States
• Alea Research /ID# 234789 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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