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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Antidepressant + placebo
Antidepressant + cariprazine (0.1-0.3 mg/day)
Antidepressant + cariprazine (1-2 mg/d)
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Adjunctive, Depression, Major Depressive Disorder (MDD)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forest Investigative Site 040
  • Forest Investigative Site 038
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site 013
  • Forest Investigative Site 041
  • Forest Investigative Site
  • Forest Investigative Site 025
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site 007
  • Forest Investigative Site 012
  • Forest Investigative Site 033
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site 042
  • Forest Investigative Site 034
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site 001
  • Forest Investigative Site 043
  • Forest Investigative Site 020
  • Forest Investigative Site 039
  • Forest Investigative Site 029
  • Forest Investigative Site 032
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site 015
  • Forest Investigative Site 006
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site 023
  • Forest Investigative Site 031
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Cariprazine 0.1 - 0.3 mg

Cariprazine 1.0 - 2.0 mg

Arm Description

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose

Outcomes

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MADRS)
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.

Secondary Outcome Measures

Clinical Global Impression - Improvement (CGI-I)
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.

Full Information

First Posted
February 26, 2009
Last Updated
February 12, 2019
Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00854100
Brief Title
Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder
Official Title
A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 30, 2009 (Actual)
Primary Completion Date
December 6, 2010 (Actual)
Study Completion Date
December 6, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Adjunctive, Depression, Major Depressive Disorder (MDD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo
Arm Title
Cariprazine 0.1 - 0.3 mg
Arm Type
Experimental
Arm Description
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose
Arm Title
Cariprazine 1.0 - 2.0 mg
Arm Type
Experimental
Arm Description
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose
Intervention Type
Drug
Intervention Name(s)
Antidepressant + placebo
Intervention Description
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
Intervention Type
Drug
Intervention Name(s)
Antidepressant + cariprazine (0.1-0.3 mg/day)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Antidepressant + cariprazine (1-2 mg/d)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Description
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.
Time Frame
Baseline (Week 8) to Week 16
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Improvement (CGI-I)
Description
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.
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hayes, PhD
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 040
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Forest Investigative Site 038
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Forest Investigative Site
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Forest Investigative Site
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Forest Investigative Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Forest Investigative Site
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Forest Investigative Site 013
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Forest Investigative Site 041
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Forest Investigative Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Forest Investigative Site 025
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Forest Investigative Site
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Forest Investigative Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Forest Investigative Site 007
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Forest Investigative Site 012
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Forest Investigative Site 033
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Forest Investigative Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Forest Investigative Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Forest Investigative Site 042
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Forest Investigative Site 034
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01267
Country
United States
Facility Name
Forest Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Forest Investigative Site
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Forest Investigative Site 001
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Forest Investigative Site 043
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Forest Investigative Site 020
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Forest Investigative Site 039
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Forest Investigative Site 029
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Forest Investigative Site 032
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Forest Investigative Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Forest Investigative Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Forest Investigative Site 015
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Forest Investigative Site 006
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Forest Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Forest Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Forest Investigative Site 023
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 031
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Forest Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
Forest Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Forest Investigative Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Forest Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30045066
Citation
Fava M, Durgam S, Earley W, Lu K, Hayes R, Laszlovszky I, Nemeth G. Efficacy of adjunctive low-dose cariprazine in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. 2018 Nov;33(6):312-321. doi: 10.1097/YIC.0000000000000235.
Results Reference
derived

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

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