Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

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

Key facts

Study ID

NCT01715805

Run by

Forest Laboratories

People needed

1022

Starts

2012-11-15

Expected to finish

2016-06-24

Last updated by the study team

2019-08-28

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 specific procedure
• Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
• Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at Visits 1 and 2

You may not qualify if…

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

Where it is running

• Forest Investigative Site 018 — Little Rock, Arkansas, United States
• Forest Investigative Site 029 — Little Rock, Arkansas, United States
• Forest Investigative Site 084 — Cerritos, California, United States
• Forest Investigative Site 085 — Culver City, California, United States
• Forest Investigative Site 082 — Garden Grove, California, United States
• Forest Investigative Site 022 — Newport Beach, California, United States
• Forest Investigative Site 004 — Oceanside, California, United States
• Forest Investigative Site 090 — Rancho Mirage, California, United States
• Forest Investigative Site 078 — Redlands, California, United States
• Forest Investigative Site 080 — Redlands, California, United States
• Forest Investigative Site 007 — San Diego, California, United States
• Forest Investigative Site 054 — San Diego, California, United States
• Forest Investigative Site 031 — Temecula, California, United States
• Forest Investigative Site 048 — Denver, Colorado, 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 026 — Miami, Florida, United States
• Forest Investigative Site 075 — Miami, Florida, United States
• Forest Investigative Site 027 — North Miami, Florida, United States
• Forest Investigative Site 074 — North Miami, Florida, United States
• Forest Investigative Site 036 — Oakland Park, Florida, United States
• Forest Investigative Site 032 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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