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Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cariprazine
Antidepressant Therapy (ADT)
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, MDD, Depression

Eligibility Criteria

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

Inclusion Criteria:

  • Patients who have provided consent prior to any study specific procedures
  • 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)
  • 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.

Exclusion Criteria:

  • Patients who do not meet the DSM-IV-TR criteria for MDD.

Sites / Locations

  • Forest Investigative Site 032
  • Forest Investigative Site 109
  • Forest Investigative Site 105
  • Forest Investigative Site 018
  • Forest Investigative Site 029
  • Forest Investigative Site 082
  • Forest Investigative Site 107
  • Forest Investigative Site 104
  • Forest Investigative Site 022
  • Forest Investigative Site 004
  • Forest Investigative Site 078
  • Forest Investigative Site 080
  • Forest Investigative Site 113
  • Forest Investigative Site 054
  • Forest Investigative Site 007
  • Forest Investigative Site 031
  • Forest Investigative Site 048
  • Forest Investigative Site 114
  • Forest Investigative Site 037
  • Forest Investigative Site 053
  • Forest Investigative Site 023
  • Forest Investigative Site 071
  • Forest Investigative Site 006
  • Forest Investigative Site 112
  • Forest Investigative Site 026
  • Forest Investigative Site 075
  • Forest Investigative Site 027
  • Forest Investigative Site 074
  • Forest Investigative Site 036
  • Forest Investigative Site 051
  • Forest Investigative Site 044
  • Forest Investigative Site 008
  • Forest Investigative Site 019
  • Forest Investigative Site 060
  • Forest Investigative Site 024
  • Forest Investigative Site 017
  • Forest Investigative Site 047
  • Forest Investigative Site 070
  • Forest Investigative Site 013
  • Forest Investigative Site 063
  • Forest Investigative Site 062
  • Forest Investigative Site 072
  • Forest Investigative Site 010
  • Forest Investigative Site 068
  • Forest Investigative Site 061
  • Forest Investigative Site 042
  • Forest Investigative Site 065
  • Forest Investigative Site 073
  • Forest Investigative Site 049
  • Forest Investigative Site 077
  • Forest Investigative Site 110
  • Forest Investigative Site 046
  • Forest Investigative Site 045
  • Forest Investigative Site 103
  • Forest Investigative Site 106
  • Forest Investigative Site 014
  • Forest Investigative Site 058
  • Forest Investigative Site 076
  • Forest Investigative Site 028
  • Forest Investigative Site 016
  • Forest Investigative Site 025
  • Forest Investigative Site 050
  • Forest Investigative Site 067
  • Forest Investigative Site 011
  • Forest Investigative Site 015
  • Forest Investigative Site 055
  • Forest Investigative Site 066
  • Forest Investigative Site 064
  • Forest Investigative Site 038
  • Forest Investigative Site 035
  • Forest Investigative Site 039
  • Forest Investigative Site 003
  • Forest Investigative Site 052
  • Forest Investigative Site 102
  • Forest Investigative Site 059
  • Forest Investigative Site 001
  • Forest Investigative Site 079
  • Forest Investigative Site 005
  • Forest Investigative Site 108
  • Forest Investigative Site 069
  • Forest Investigative Site 111
  • Forest Investigative Site 041
  • Forest Investigative Site 081
  • Forest Investigative Site 100
  • Forest Investigative Site 043
  • Forest Investigative Site 101
  • Forest Investigative Site 056
  • Forest Investigative Site 057
  • Forest Investigative Site 033
  • Forest Investigative Site 034

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cariprazine + ADT

Arm Description

Cariprazine, 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.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.
Number of Participants With Newly Emergent Adverse Events (NEAEs) in the Safety Follow-up Period
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A NEAE is a new AE that occurred during the 2-week Safety Follow-up Period.
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance.
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance.
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report.
Number of Participants With Extrapyramidal Symptom (EPS)-Related TEAEs
Extrapyramidal symptoms are drug-induced movement disorders such as dystonia, akathisia, parkinsonism, bradykinesia, tremor, and tardive dyskinesia.
Number of Participants in the Most Severe Suicidal Ideation and Suicidal Behavior Recorded on the C-SSRS During the Treatment Period
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent). The C-SSRS also captures information about the intensity of ideation, specifically the frequency, duration, controllability, deterrents, and reasons for the most severe types of ideation. Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior to 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes.
Number of Participants With Treatment-Emergent Ocular Events
A TEAE is an AE that occurs or worsens after receiving study drug. Ocular events are adverse events related to the eye.
Change From Baseline in the Arizona Sexual Experiences Scale (ASEX) Score
The ASEX is a participant-completed scale to evaluate overall sexual experiences over the previous 7 days consisting of 5 questions answered on a scale of 1 (best) to 6 (worst) for a total possible score of 3 to 30 (2 questions were only answered if the participant was sexually active in the past week), higher score indicates greater sexual dysfunction. There are different forms for males and females. A negative change from Baseline indicates improvement.

Secondary Outcome Measures

Full Information

First Posted
April 22, 2013
Last Updated
July 29, 2019
Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01838876
Brief Title
Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder
Official Title
A Phase 3, Long-term, Open-label Study of Safety and Tolerability of Cariprazine as Adjunctive Therapy in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 29, 2013 (Actual)
Primary Completion Date
July 27, 2015 (Actual)
Study Completion Date
July 27, 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

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, MDD, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
442 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cariprazine + ADT
Arm Type
Experimental
Arm Description
Cariprazine, 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.
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Intervention Description
Cariprazine capsules 0.5 mg, 1.0 mg, and 1.5 mg; Cariprazine doses 1.5, 3.0, or 4.5 mg/day (d); patients will be titrated to a starting dose of 3.0 mg/d. Patients can stay on 3.0 mg/d or the dose can be adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability. Oral administration.
Intervention Type
Drug
Intervention Name(s)
Antidepressant Therapy (ADT)
Intervention Description
ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its respective FDA approved package insert for each drug
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.
Time Frame
First dose of study drug to last dose of study drug in the 26-week Treatment Period and within 30 days of last dose of study drug for participants who did not participate in the 2-week Safety Follow-up Period (Up to 30 weeks)
Title
Number of Participants With Newly Emergent Adverse Events (NEAEs) in the Safety Follow-up Period
Description
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A NEAE is a new AE that occurred during the 2-week Safety Follow-up Period.
Time Frame
2 weeks following the 26-week Treatment Period
Title
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Description
Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance.
Time Frame
Baseline (Week 0) to up to 26 weeks in the Treatment Period
Title
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
Description
Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance.
Time Frame
Baseline (Week 0) to up to 26 weeks in the Treatment Period plus a 2-week Safety Follow-up Period (Up to 28 weeks)
Title
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
Description
A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report.
Time Frame
Baseline (Week 0) to up to 26 weeks
Title
Number of Participants With Extrapyramidal Symptom (EPS)-Related TEAEs
Description
Extrapyramidal symptoms are drug-induced movement disorders such as dystonia, akathisia, parkinsonism, bradykinesia, tremor, and tardive dyskinesia.
Time Frame
First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks)
Title
Number of Participants in the Most Severe Suicidal Ideation and Suicidal Behavior Recorded on the C-SSRS During the Treatment Period
Description
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent). The C-SSRS also captures information about the intensity of ideation, specifically the frequency, duration, controllability, deterrents, and reasons for the most severe types of ideation. Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior to 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes.
Time Frame
Baseline (Lead-in study Baseline for roll-over participants and prior to first dose in this study for new participants) to Week 26 in this study
Title
Number of Participants With Treatment-Emergent Ocular Events
Description
A TEAE is an AE that occurs or worsens after receiving study drug. Ocular events are adverse events related to the eye.
Time Frame
First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks)
Title
Change From Baseline in the Arizona Sexual Experiences Scale (ASEX) Score
Description
The ASEX is a participant-completed scale to evaluate overall sexual experiences over the previous 7 days consisting of 5 questions answered on a scale of 1 (best) to 6 (worst) for a total possible score of 3 to 30 (2 questions were only answered if the participant was sexually active in the past week), higher score indicates greater sexual dysfunction. There are different forms for males and females. A negative change from Baseline indicates improvement.
Time Frame
Baseline (Lead-in study Baseline for roll-over participants and prior to first dose of this study for new participants) to End of Treatment (Up to Week 26) in this study

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: Patients who have provided consent prior to any study specific procedures 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) 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. Exclusion Criteria: Patients who do not meet the DSM-IV-TR criteria for MDD.
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 032
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Forest Investigative Site 109
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Forest Investigative Site 105
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Forest Investigative Site 018
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Forest Investigative Site 029
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Forest Investigative Site 082
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Forest Investigative Site 107
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Forest Investigative Site 104
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Forest Investigative Site 022
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Forest Investigative Site 004
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Forest Investigative Site 078
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Forest Investigative Site 080
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Forest Investigative Site 113
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Forest Investigative Site 054
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Forest Investigative Site 007
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Forest Investigative Site 031
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Forest Investigative Site 048
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Forest Investigative Site 114
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Forest Investigative Site 037
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Forest Investigative Site 053
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Forest Investigative Site 023
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Forest Investigative Site 071
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Forest Investigative Site 006
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Forest Investigative Site 112
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Forest Investigative Site 026
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Forest Investigative Site 075
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Forest Investigative Site 027
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Forest Investigative Site 074
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Forest Investigative Site 036
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Forest Investigative Site 051
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Forest Investigative Site 044
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Forest Investigative Site 008
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Forest Investigative Site 019
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Forest Investigative Site 060
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Forest Investigative Site 024
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Forest Investigative Site 017
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Forest Investigative Site 047
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Forest Investigative Site 070
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Forest Investigative Site 013
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Forest Investigative Site 063
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Forest Investigative Site 062
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Forest Investigative Site 072
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Forest Investigative Site 010
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Forest Investigative Site 068
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Forest Investigative Site 061
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Forest Investigative Site 042
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Forest Investigative Site 065
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Forest Investigative Site 073
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Forest Investigative Site 049
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Forest Investigative Site 077
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Forest Investigative Site 110
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Forest Investigative Site 046
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Forest Investigative Site 045
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760
Country
United States
Facility Name
Forest Investigative Site 103
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Forest Investigative Site 106
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Forest Investigative Site 014
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Forest Investigative Site 058
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Forest Investigative Site 076
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Forest Investigative Site 028
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
Facility Name
Forest Investigative Site 016
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Forest Investigative Site 025
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Forest Investigative Site 050
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Forest Investigative Site 067
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Forest Investigative Site 011
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Forest Investigative Site 015
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Forest Investigative Site 055
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Forest Investigative Site 066
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Forest Investigative Site 064
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Forest Investigative Site 038
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
72112
Country
United States
Facility Name
Forest Investigative Site 035
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Forest Investigative Site 039
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Forest Investigative Site 003
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Forest Investigative Site 052
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Forest Investigative Site 102
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
Facility Name
Forest Investigative Site 059
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Forest Investigative Site 001
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Forest Investigative Site 079
City
Austin
State/Province
Texas
ZIP/Postal Code
78732
Country
United States
Facility Name
Forest Investigative Site 005
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Forest Investigative Site 108
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Forest Investigative Site 069
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Forest Investigative Site 111
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Forest Investigative Site 041
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Forest Investigative Site 081
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Forest Investigative Site 100
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
Facility Name
Forest Investigative Site 043
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Forest Investigative Site 101
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Forest Investigative Site 056
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Facility Name
Forest Investigative Site 057
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Forest Investigative Site 033
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Forest Investigative Site 034
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder

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