Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

The objective of this study is to evaluate the long-term safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD).

Key facts

Study ID

NCT01838876

Run by

Forest Laboratories

People needed

442

Starts

2013-04-29

Expected to finish

2015-07-27

Last updated by the study team

2019-08-21

Who can join

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

You may qualify if…

• Patients who have provided consent prior to any study specific procedures
• Meets the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for MDD
• New patients must have ongoing inadequate response to protocol allowed ADTs as reported in Antidepressant Treatment Response Questionnaire (ATRQ)
• For rollover patients from RGH-MD-72 [NCT01715805], completion of Study RGH-MD-72 (either double-blind or single-blind treatment periods) with continued ADT treatment.

You may not qualify if…

• Patients who do not meet the DSM-IV-TR criteria for MDD.

Where it is running

• Forest Investigative Site 109 — Tucson, Arizona, United States
• Forest Investigative Site 105 — Fayetteville, Arkansas, United States
• Forest Investigative Site 018 — Little Rock, Arkansas, United States
• Forest Investigative Site 029 — Little Rock, Arkansas, United States
• Forest Investigative Site 082 — Garden Grove, California, United States
• Forest Investigative Site 107 — Long Beach, California, United States
• Forest Investigative Site 104 — National City, California, United States
• Forest Investigative Site 022 — Newport Beach, California, United States
• Forest Investigative Site 004 — Oceanside, California, United States
• Forest Investigative Site 078 — Rancho Mirage, California, United States
• Forest Investigative Site 080 — Redlands, California, United States
• Forest Investigative Site 113 — San Diego, California, United States
• Forest Investigative Site 054 — San Diego, California, United States
• Forest Investigative Site 007 — San Diego, California, United States
• Forest Investigative Site 031 — Temecula, California, United States
• Forest Investigative Site 048 — Denver, Colorado, United States
• Forest Investigative Site 114 — Norwich, Connecticut, United States
• Forest Investigative Site 037 — Coral Springs, Florida, United States
• Forest Investigative Site 053 — Fort Myers, Florida, United States
• Forest Investigative Site 023 — Hallandale, Florida, United States
• Forest Investigative Site 071 — Hialeah, Florida, United States
• Forest Investigative Site 006 — Leesburg, Florida, United States
• Forest Investigative Site 112 — Maitland, Florida, United States
• Forest Investigative Site 026 — Miami, Florida, United States
• Forest Investigative Site 032 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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