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Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Cariprazine
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 Major depressive disorder, Depression

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female outpatients 18 to 65 years of age, inclusive.
  • Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive disorder (MDD).
  • Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration.
  • Ongoing inadequate response to protocol allowed antidepressant therapy (ADT).

Exclusion Criteria:

  • Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,
  • Women who are pregnant, or planning to become pregnant or breastfeed during the study or not practicing reliable contraception that will continue through out the study.

  • History of meeting DSM-IV-TR criteria for:

    1. Depressive episode with psychotic or catatonic features.
    2. Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode.
    3. Schizophrenia, schizoaffective, or other psychotic disorder.
    4. Obsessive-compulsive disorder.
    5. Bulimia or anorexia nervosa.
    6. Dementia, amnesic, or other cognitive disorder.
    7. Mental retardation.
  • Participants considered a suicide risk.

Sites / Locations

  • Forest Investigative Site 077
  • Forest Investigative Site 019
  • Forest Investigative Site 039
  • Forest Investigative Site 015
  • Forest Investigative Site 050
  • Forest Investigative Site 008
  • Forest Investigative Site 066
  • Forest Investigative Site 063
  • Forest Investigative Site 029
  • Forest Investigative Site 012
  • Forest Investigative Site 023
  • Forest Investigative Site 026
  • Forest Investigative Site 062
  • Forest Investigative Site 065
  • Forest Investigative Site 074
  • Forest Investigative Site 040
  • Forest Investigative Site 068
  • Forest Investigative Site 061
  • Forest Investigative Site 038
  • Forest Investigative Site 030
  • Forest Investigative Site 076
  • Forest Investigative Site 037
  • Forest Investigative Site 067
  • Forest Investigative Site 049
  • Forest Investigative Site 047
  • Forest Investigative Site 021
  • Forest Investigative Site 022
  • Forest Investigative Site 027
  • Forest Investigative Site 069
  • Forest Investigative Site 025
  • Forest Investigative Site 031
  • Forest Investigative Site 048
  • Forest Investigative Site 024
  • Forest Investigative Site 020
  • Forest Investigative Site 070
  • Forest Investigative Site 080
  • Forest Investigative Site 028
  • Forest Investigative Site 032
  • Forest Investigative Site 034
  • Forest Investigative Site 203
  • Forest Investigative Site 201
  • Forest Investigative Site 206
  • Forest Investigative Site 205
  • Forest Investigative Site 204
  • Forest Investigative Site 208
  • Forest Investigative Site 207
  • Forest Investigative Site 202
  • Forest Investigative Site 301
  • Forest Investigative Site 302
  • Forest Investigative Site 304
  • Forest Investigative Site 303
  • Forest Investigative Site 305
  • Forest Investigative Site 308
  • Forest Investigative Site 307
  • Forest Investigative Site 602
  • Forest Investigative Site 603
  • Forest Investigative Site 604
  • Forest Investigative Site 606
  • Forest Investigative Site 601
  • Forest Investigative Site 605
  • Forest Investigative Site 607
  • Forest Investigative Site 803
  • Forest Investigative Site 802
  • Forest Investigative Site 801
  • Forest Investigative Site 705
  • Forest Investigative Site 703
  • Forest Investigative Site 704
  • Forest Investigative Site 702
  • Forest Investigative Site 701
  • Forest Investigative Site 710
  • Forest Investigative Site 709
  • Forest Investigative Site 706

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Cariprazine 1-2 mg

Cariprazine 2-4.5 mg

Arm Description

Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Outcomes

Primary Outcome Measures

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.

Secondary Outcome Measures

Change From Baseline in the Sheehan Disability Scale (SDS) Total Score at Week 8
The SDS measures an individual's perception of the extent to which his or her emotional symptoms are disrupting his or her functioning in 3 domains, work/school, social life/leisure activities, and family life/home responsibilities. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement.

Full Information

First Posted
November 8, 2011
Last Updated
March 29, 2018
Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01469377
Brief Title
Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant 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
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 15, 2011 (Actual)
Primary Completion Date
December 12, 2013 (Actual)
Study Completion Date
December 12, 2013 (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
An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study consisted of approximately 2 weeks of screening and washout followed by 8 weeks of double-blind treatment followed by a 1 week safety follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depressive disorder, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
819 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Arm Title
Cariprazine 1-2 mg
Arm Type
Experimental
Arm Description
Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Arm Title
Cariprazine 2-4.5 mg
Arm Type
Experimental
Arm Description
Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo was supplied in capsules
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Intervention Description
Cariprazine was supplied in capsules.
Primary Outcome Measure Information:
Title
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8
Description
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Time Frame
Baseline to Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score at Week 8
Description
The SDS measures an individual's perception of the extent to which his or her emotional symptoms are disrupting his or her functioning in 3 domains, work/school, social life/leisure activities, and family life/home responsibilities. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement.
Time Frame
Baseline to Week 8

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: Male or female outpatients 18 to 65 years of age, inclusive. Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive disorder (MDD). Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration. Ongoing inadequate response to protocol allowed antidepressant therapy (ADT). Exclusion Criteria: Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD, Women who are pregnant, or planning to become pregnant or breastfeed during the study or not practicing reliable contraception that will continue through out the study. History of meeting DSM-IV-TR criteria for: Depressive episode with psychotic or catatonic features. Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode. Schizophrenia, schizoaffective, or other psychotic disorder. Obsessive-compulsive disorder. Bulimia or anorexia nervosa. Dementia, amnesic, or other cognitive disorder. Mental retardation. Participants considered a suicide risk.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willie Earley, MD
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 077
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Forest Investigative Site 019
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Forest Investigative Site 039
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Forest Investigative Site 015
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Forest Investigative Site 050
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Forest Investigative Site 008
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Forest Investigative Site 066
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Forest Investigative Site 063
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Forest Investigative Site 029
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Forest Investigative Site 012
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Forest Investigative Site 023
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Forest Investigative Site 026
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 062
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Forest Investigative Site 065
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Forest Investigative Site 074
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Forest Investigative Site 040
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Forest Investigative Site 068
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site 061
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Forest Investigative Site 038
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Forest Investigative Site 030
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Forest Investigative Site 076
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Forest Investigative Site 037
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Forest Investigative Site 067
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Forest Investigative Site 049
City
New York
State/Province
New York
ZIP/Postal Code
10168
Country
United States
Facility Name
Forest Investigative Site 047
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Forest Investigative Site 021
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Forest Investigative Site 022
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Forest Investigative Site 027
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Forest Investigative Site 069
City
Bridgeville
State/Province
Pennsylvania
ZIP/Postal Code
15017
Country
United States
Facility Name
Forest Investigative Site 025
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Forest Investigative Site 031
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19604
Country
United States
Facility Name
Forest Investigative Site 048
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 024
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Forest Investigative Site 020
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Forest Investigative Site 070
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Forest Investigative Site 080
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site 028
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Forest Investigative Site 032
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Forest Investigative Site 034
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Forest Investigative Site 203
City
Tallinn
ZIP/Postal Code
10614
Country
Estonia
Facility Name
Forest Investigative Site 201
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Forest Investigative Site 206
City
Tallinn
ZIP/Postal Code
11615
Country
Estonia
Facility Name
Forest Investigative Site 205
City
Tallinn
ZIP/Postal Code
13517
Country
Estonia
Facility Name
Forest Investigative Site 204
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Forest Investigative Site 208
City
Tartu
ZIP/Postal Code
50417
Country
Estonia
Facility Name
Forest Investigative Site 207
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Forest Investigative Site 202
City
Võru
ZIP/Postal Code
65608
Country
Estonia
Facility Name
Forest Investigative Site 301
City
Helsinki
ZIP/Postal Code
100
Country
Finland
Facility Name
Forest Investigative Site 302
City
Helsinki
ZIP/Postal Code
100
Country
Finland
Facility Name
Forest Investigative Site 304
City
Helsinki
ZIP/Postal Code
100
Country
Finland
Facility Name
Forest Investigative Site 303
City
Helsinki
ZIP/Postal Code
40100
Country
Finland
Facility Name
Forest Investigative Site 305
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
Facility Name
Forest Investigative Site 308
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Forest Investigative Site 307
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
Forest Investigative Site 602
City
Banska Stiavnica
ZIP/Postal Code
96901
Country
Slovakia
Facility Name
Forest Investigative Site 603
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Facility Name
Forest Investigative Site 604
City
Bratislava
ZIP/Postal Code
82007
Country
Slovakia
Facility Name
Forest Investigative Site 606
City
Bratislava
ZIP/Postal Code
85101
Country
Slovakia
Facility Name
Forest Investigative Site 601
City
Michalovce
ZIP/Postal Code
7101
Country
Slovakia
Facility Name
Forest Investigative Site 605
City
Rimavska Sobota
ZIP/Postal Code
97901
Country
Slovakia
Facility Name
Forest Investigative Site 607
City
Rimavska Sobota
ZIP/Postal Code
97912
Country
Slovakia
Facility Name
Forest Investigative Site 803
City
Lund
ZIP/Postal Code
22222
Country
Sweden
Facility Name
Forest Investigative Site 802
City
Malmö
ZIP/Postal Code
21152
Country
Sweden
Facility Name
Forest Investigative Site 801
City
Stockholm
ZIP/Postal Code
17145
Country
Sweden
Facility Name
Forest Investigative Site 705
City
Stepanivka
State/Province
Kherson
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Forest Investigative Site 703
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Forest Investigative Site 704
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Forest Investigative Site 702
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
Facility Name
Forest Investigative Site 701
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Forest Investigative Site 710
City
Lugansk
ZIP/Postal Code
91045
Country
Ukraine
Facility Name
Forest Investigative Site 709
City
Odesa
ZIP/Postal Code
65014
Country
Ukraine
Facility Name
Forest Investigative Site 706
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
27046309
Citation
Durgam S, Earley W, Guo H, Li D, Nemeth G, Laszlovszky I, Fava M, Montgomery SA. Efficacy and safety of adjunctive cariprazine in inadequate responders to antidepressants: a randomized, double-blind, placebo-controlled study in adult patients with major depressive disorder. J Clin Psychiatry. 2016 Mar;77(3):371-8. doi: 10.4088/JCP.15m10070.
Results Reference
derived

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Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder

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