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Trial record 81 of 89 for:    DESVENLAFAXINE

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

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ClinicalTrials.gov Identifier: NCT01838876
Recruitment Status : Completed
First Posted : April 24, 2013
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Cariprazine Drug: Antidepressant Therapy (ADT) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 442 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Long-term, Open-label Study of Safety and Tolerability of Cariprazine as Adjunctive Therapy in Major Depressive Disorder
Actual Study Start Date : April 29, 2013
Actual Primary Completion Date : July 27, 2015
Actual Study Completion Date : July 27, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: Cariprazine + ADT
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.
Drug: Cariprazine
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.

Drug: Antidepressant Therapy (ADT)
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 Measures :
  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period [ 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) ]
    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.

  2. Number of Participants With Newly Emergent Adverse Events (NEAEs) in the Safety Follow-up Period [ Time Frame: 2 weeks following the 26-week Treatment 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.

  3. Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters [ Time Frame: Baseline (Week 0) to up to 26 weeks in the Treatment Period ]
    Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance.

  4. Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters [ 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) ]
    Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance.

  5. Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG) [ Time Frame: Baseline (Week 0) to up to 26 weeks ]
    A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report.

  6. Number of Participants With Extrapyramidal Symptom (EPS)-Related TEAEs [ 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) ]
    Extrapyramidal symptoms are drug-induced movement disorders such as dystonia, akathisia, parkinsonism, bradykinesia, tremor, and tardive dyskinesia.

  7. Number of Participants in the Most Severe Suicidal Ideation and Suicidal Behavior Recorded on the C-SSRS During the Treatment Period [ 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 ]
    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.

  8. Number of Participants With Treatment-Emergent Ocular Events [ 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) ]
    A TEAE is an AE that occurs or worsens after receiving study drug. Ocular events are adverse events related to the eye.

  9. Change From Baseline in the Arizona Sexual Experiences Scale (ASEX) Score [ 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 ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838876


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Locations
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United States, Arizona
Forest Investigative Site 032
Tucson, Arizona, United States, 85710
Forest Investigative Site 109
Tucson, Arizona, United States, 85724
United States, Arkansas
Forest Investigative Site 105
Fayetteville, Arkansas, United States, 72703
Forest Investigative Site 018
Little Rock, Arkansas, United States, 72211
Forest Investigative Site 029
Little Rock, Arkansas, United States, 72211
United States, California
Forest Investigative Site 082
Garden Grove, California, United States, 92845
Forest Investigative Site 107
Long Beach, California, United States, 90822
Forest Investigative Site 104
National City, California, United States, 91950
Forest Investigative Site 022
Newport Beach, California, United States, 92660
Forest Investigative Site 004
Oceanside, California, United States, 92056
Forest Investigative Site 078
Rancho Mirage, California, United States, 92270
Forest Investigative Site 080
Redlands, California, United States, 92374
Forest Investigative Site 113
San Diego, California, United States, 92102
Forest Investigative Site 054
San Diego, California, United States, 92108
Forest Investigative Site 007
San Diego, California, United States, 92123
Forest Investigative Site 031
Temecula, California, United States, 92591
United States, Colorado
Forest Investigative Site 048
Denver, Colorado, United States, 80239
United States, Connecticut
Forest Investigative Site 114
Norwich, Connecticut, United States, 06360
United States, Florida
Forest Investigative Site 037
Coral Springs, Florida, United States, 33067
Forest Investigative Site 053
Fort Myers, Florida, United States, 33912
Forest Investigative Site 023
Hallandale Beach, Florida, United States, 33009
Forest Investigative Site 071
Hialeah, Florida, United States, 33012
Forest Investigative Site 006
Leesburg, Florida, United States, 34748
Forest Investigative Site 112
Maitland, Florida, United States, 32751
Forest Investigative Site 026
Miami, Florida, United States, 33145
Forest Investigative Site 075
Miami, Florida, United States, 33165
Forest Investigative Site 027
North Miami, Florida, United States, 33161
Forest Investigative Site 074
North Miami, Florida, United States, 33161
Forest Investigative Site 036
Oakland Park, Florida, United States, 33334
Forest Investigative Site 051
Orlando, Florida, United States, 32803
Forest Investigative Site 044
South Miami, Florida, United States, 33143
Forest Investigative Site 008
Tampa, Florida, United States, 33613
Forest Investigative Site 019
Winter Park, Florida, United States, 32789
United States, Georgia
Forest Investigative Site 060
Atlanta, Georgia, United States, 30329
Forest Investigative Site 024
Atlanta, Georgia, United States, 30331
Forest Investigative Site 017
Marietta, Georgia, United States, 30060
Forest Investigative Site 047
Smyrna, Georgia, United States, 30080
United States, Illinois
Forest Investigative Site 070
Chicago, Illinois, United States, 60612
Forest Investigative Site 013
Hoffman Estates, Illinois, United States, 60169
Forest Investigative Site 063
Libertyville, Illinois, United States, 60048
Forest Investigative Site 062
Maywood, Illinois, United States, 60153
Forest Investigative Site 072
Naperville, Illinois, United States, 60563
Forest Investigative Site 010
Oak Brook, Illinois, United States, 60523
Forest Investigative Site 068
Skokie, Illinois, United States, 60076
United States, Indiana
Forest Investigative Site 061
Indianapolis, Indiana, United States, 46260
Forest Investigative Site 042
Lafayette, Indiana, United States, 47905
United States, Kansas
Forest Investigative Site 065
Overland Park, Kansas, United States, 66211
United States, Louisiana
Forest Investigative Site 073
New Orleans, Louisiana, United States, 70115
United States, Maryland
Forest Investigative Site 049
Gaithersburg, Maryland, United States, 20877
Forest Investigative Site 077
Rockville, Maryland, United States, 20850
Forest Investigative Site 110
Rockville, Maryland, United States, 20852
United States, Massachusetts
Forest Investigative Site 046
Boston, Massachusetts, United States, 02131
Forest Investigative Site 045
Natick, Massachusetts, United States, 01760
United States, Missouri
Forest Investigative Site 103
Saint Charles, Missouri, United States, 63304
United States, New Jersey
Forest Investigative Site 106
Berlin, New Jersey, United States, 08009
Forest Investigative Site 014
Toms River, New Jersey, United States, 08755
United States, New Mexico
Forest Investigative Site 058
Albuquerque, New Mexico, United States, 87109
United States, New York
Forest Investigative Site 076
Bronx, New York, United States, 10467
Forest Investigative Site 028
Brooklyn, New York, United States, 11214
Forest Investigative Site 016
New York, New York, United States, 10023
Forest Investigative Site 025
Staten Island, New York, United States, 10305
United States, North Carolina
Forest Investigative Site 050
Durham, North Carolina, United States, 27710
United States, North Dakota
Forest Investigative Site 067
Bismarck, North Dakota, United States, 58501
United States, Ohio
Forest Investigative Site 011
Cincinnati, Ohio, United States, 45219
Forest Investigative Site 015
Cincinnati, Ohio, United States, 45227
Forest Investigative Site 055
Columbus, Ohio, United States, 43210
Forest Investigative Site 066
Mason, Ohio, United States, 45040
Forest Investigative Site 064
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Forest Investigative Site 038
Oklahoma City, Oklahoma, United States, 72112
Forest Investigative Site 035
Oklahoma City, Oklahoma, United States, 73103
Forest Investigative Site 039
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Forest Investigative Site 003
Portland, Oregon, United States, 97210
United States, Pennsylvania
Forest Investigative Site 052
Allentown, Pennsylvania, United States, 18104
Forest Investigative Site 102
Norristown, Pennsylvania, United States, 19403
United States, Rhode Island
Forest Investigative Site 059
Lincoln, Rhode Island, United States, 02865
United States, South Carolina
Forest Investigative Site 001
Charleston, South Carolina, United States, 29425
United States, Texas
Forest Investigative Site 079
Austin, Texas, United States, 78732
Forest Investigative Site 005
Houston, Texas, United States, 77008
Forest Investigative Site 108
The Woodlands, Texas, United States, 77381
Forest Investigative Site 069
Wichita Falls, Texas, United States, 76309
United States, Utah
Forest Investigative Site 111
Murray, Utah, United States, 84123
United States, Virginia
Forest Investigative Site 041
Charlottesville, Virginia, United States, 22903
United States, Washington
Forest Investigative Site 081
Bellevue, Washington, United States, 98007
Forest Investigative Site 100
Bothell, Washington, United States, 98011
Forest Investigative Site 043
Seattle, Washington, United States, 98104
United States, Wisconsin
Forest Investigative Site 101
Middleton, Wisconsin, United States, 53562
Forest Investigative Site 056
Milwaukee, Wisconsin, United States, 53227
Forest Investigative Site 057
Waukesha, Wisconsin, United States, 53188
Puerto Rico
Forest Investigative Site 033
San Juan, Puerto Rico, 00918
Forest Investigative Site 034
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
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Study Director: Willie Earley, MD Allergan

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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01838876     History of Changes
Other Study ID Numbers: RGH-MD-76
First Posted: April 24, 2013    Key Record Dates
Results First Posted: August 21, 2019
Last Update Posted: August 21, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Forest Laboratories:
Major Depressive Disorder
MDD
Depression
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Cariprazine
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs