Completed
A Phase 3, Long-term, Open-label Study of Safety and Tolerability of Cariprazine as Adjunctive Therapy in Major Depressive Disorder
What is being tested
Cariprazine
+ Antidepressant Therapy (ADT)
Drug
Who is being recruted
Behavior+4
+ Mental Disorders
+ Behavioral Symptoms
From 18 to 65 Years
+5 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: April 2013
Summary
Principal SponsorForest Laboratories
Last updated: August 21, 2019
Sourced from a government-validated database.Claim as a partner
Study start date: April 29, 2013
Actual date on which the first participant was enrolled.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).
Principal SponsorForest Laboratories
Last updated: August 21, 2019
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
442 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
BehaviorMental DisordersBehavioral SymptomsDepressive DisorderMood DisordersDepressionDepressive Disorder, Major
Criteria
4 inclusion criteria required to participate
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
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)
Patients who have provided consent prior to any study specific procedures
1 exclusion criteria prevent from participating
Patients who do not meet the DSM-IV-TR criteria for MDD
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalCariprazine, flexible dose (titrated to a dose of 3.0 milligrams (mg) adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 90 locations
Forest Investigative Site 109
Tucson, United StatesForest Investigative Site 105
Fayetteville, United StatesForest Investigative Site 018
Little Rock, United StatesCompleted90 Study Centers