Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.

Key facts

Study ID

NCT00854100

Run by

Forest Laboratories

People needed

231

Starts

2009-06-30

Expected to finish

2010-12-06

Last updated by the study team

2019-03-05

Who can join

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

You may qualify if…

• Men and women, 18-65 years old
• Currently meet the DSM-IV-TR criteria for moderate to severe MDD without psychotic features.
• Previous failure to respond to adequate trials of one or two ADTs with less than 50% reduction in depressive symptoms during the present episode.

You may not qualify if…

• DSM-IV-TR based diagnosis of an axis I disorder, other than MDD, or any axis I disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1

Where it is running

• Forest Investigative Site 040 — Phoenix, Arizona, United States
• Forest Investigative Site 038 — Scottsdale, Arizona, United States
• Forest Investigative Site — Arcadia, California, United States
• Forest Investigative Site — Encino, California, United States
• Forest Investigative Site — Garden Grove, California, United States
• Forest Investigative Site — Irvine, California, United States
• Forest Investigative Site 013 — Los Alamitos, California, United States
• Forest Investigative Site 041 — National City, California, United States
• Forest Investigative Site — Oceanside, California, United States
• Forest Investigative Site 025 — Denver, Colorado, United States
• Forest Investigative Site — Norwich, Connecticut, United States
• Forest Investigative Site — Washington D.C., District of Columbia, United States
• Forest Investigative Site 007 — Jacksonville, Florida, United States
• Forest Investigative Site 012 — West Palm Beach, Florida, United States
• Forest Investigative Site 033 — Atlanta, Georgia, United States
• Forest Investigative Site — Roswell, Georgia, United States
• Forest Investigative Site — Overland Park, Kansas, United States
• Forest Investigative Site 042 — Fall River, Massachusetts, United States
• Forest Investigative Site 034 — Pittsfield, Massachusetts, United States
• Forest Investigative Site — Omaha, Nebraska, United States
• Forest Investigative Site — Cherry Hill, New Jersey, United States
• Forest Investigative Site 043 — Brooklyn, New York, United States
• Forest Investigative Site 020 — Mount Kisco, New York, United States
• Forest Investigative Site 039 — New York, New York, United States
• Forest Investigative Site 029 — New York, New York, United States

Full record on ClinicalTrials.gov

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