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

February 12, 2019 updated by: Forest Laboratories

A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Phoenix, Arizona, United States, 85050
        • Forest Investigative Site 040
      • Scottsdale, Arizona, United States, 85254
        • Forest Investigative Site 038
    • California
      • Arcadia, California, United States, 91007
        • Forest Investigative Site
      • Encino, California, United States, 91316
        • Forest Investigative Site
      • Garden Grove, California, United States, 92845
        • Forest Investigative Site
      • Irvine, California, United States, 92618
        • Forest Investigative Site
      • Los Alamitos, California, United States, 90720
        • Forest Investigative Site 013
      • National City, California, United States, 91950
        • Forest Investigative Site 041
      • Oceanside, California, United States, 92056
        • Forest Investigative Site
    • Colorado
      • Denver, Colorado, United States, 80239
        • Forest Investigative Site 025
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Forest Investigative Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Forest Investigative Site
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Forest Investigative Site 007
      • West Palm Beach, Florida, United States, 33407
        • Forest Investigative Site 012
    • Georgia
      • Atlanta, Georgia, United States, 30306
        • Forest Investigative Site 033
      • Roswell, Georgia, United States, 30076
        • Forest Investigative Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Forest Investigative Site
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • Forest Investigative Site 042
      • Pittsfield, Massachusetts, United States, 01267
        • Forest Investigative Site 034
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Forest Investigative Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Forest Investigative Site
    • New York
      • Bronx, New York, United States, 10467
        • Forest Investigative Site 001
      • Brooklyn, New York, United States, 11235
        • Forest Investigative Site 043
      • Mount Kisco, New York, United States, 10549
        • Forest Investigative Site 020
      • New York, New York, United States, 10003
        • Forest Investigative Site 039
      • New York, New York, United States, 10021
        • Forest Investigative Site 029
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Forest Investigative Site 032
    • Ohio
      • Canton, Ohio, United States, 44718
        • Forest Investigative Site
      • Dayton, Ohio, United States, 45417
        • Forest Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Forest Investigative Site 015
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Forest Investigative Site 006
      • Philadelphia, Pennsylvania, United States, 19107
        • Forest Investigative Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Forest Investigative Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative Site 023
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative Site 031
      • Nashville, Tennessee, United States, 37212
        • Forest Investigative Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Forest Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Forest Investigative Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Forest Investigative Site
      • Seattle, Washington, United States, 98104
        • Forest Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
EXPERIMENTAL: Cariprazine 0.1 - 0.3 mg
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
EXPERIMENTAL: Cariprazine 1.0 - 2.0 mg
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Baseline (Week 8) to Week 16
The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. The primary efficacy parameter was the change in MADRS score totals from the scores taken at Baseline (Week 8) and during at least one more time point up to and including Week 16.
Baseline (Week 8) to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression - Improvement (CGI-I)
Time Frame: Week 16
The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale that, in this study, will be used to rate total improvement or worsening of mental illness starting at Visit 2 (Week 2) and taken at every visit through Visit 11 (Week 16). The patient will be rated on a scale from 1 to 7, 1 indicating that the patient is very much improved and 7 indicating that the patient is very much worse. The secondary efficacy parameter was the CGI-I total score at Week 16.
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Robert Hayes, PhD, Forest Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 30, 2009

Primary Completion (ACTUAL)

December 6, 2010

Study Completion (ACTUAL)

December 6, 2010

Study Registration Dates

First Submitted

February 26, 2009

First Submitted That Met QC Criteria

February 26, 2009

First Posted (ESTIMATE)

March 2, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depressive Disorder

Clinical Trials on Antidepressant + placebo

3
Subscribe