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

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ClinicalTrials.gov Identifier: NCT01469377
Recruitment Status : Completed
First Posted : November 10, 2011
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Placebo Drug: Cariprazine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 819 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) as Adjunctive Therapy in Major Depressive Disorder
Actual Study Start Date : December 15, 2011
Actual Primary Completion Date : December 12, 2013
Actual Study Completion Date : December 12, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Placebo Comparator: Placebo
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.
Drug: Placebo
Placebo was supplied in capsules

Experimental: Cariprazine 1-2 mg
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.
Drug: Cariprazine
Cariprazine was supplied in capsules.

Experimental: Cariprazine 2-4.5 mg
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.
Drug: Cariprazine
Cariprazine was supplied in capsules.




Primary Outcome Measures :
  1. Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8 [ Time Frame: Baseline to 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 :
  1. Change From Baseline in the Sheehan Disability Scale (SDS) Total Score at Week 8 [ Time Frame: Baseline to 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.



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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:

  • 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.

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): NCT01469377


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Locations
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United States, California
Forest Investigative Site 077
Garden Grove, California, United States, 92845
Forest Investigative Site 019
National City, California, United States, 91950
Forest Investigative Site 039
Oceanside, California, United States, 92056
Forest Investigative Site 015
Orange, California, United States, 92868
Forest Investigative Site 050
Orange, California, United States, 92868
Forest Investigative Site 008
Redlands, California, United States, 92374
Forest Investigative Site 066
Sherman Oaks, California, United States, 91403
United States, Florida
Forest Investigative Site 063
Gainesville, Florida, United States, 32607
Forest Investigative Site 029
Jacksonville, Florida, United States, 32256
Forest Investigative Site 012
Kissimmee, Florida, United States, 34741
Forest Investigative Site 023
Miami, Florida, United States, 33183
Forest Investigative Site 026
Orlando, Florida, United States, 32806
United States, Georgia
Forest Investigative Site 062
Atlanta, Georgia, United States, 30328
Forest Investigative Site 065
Smyrna, Georgia, United States, 30080
United States, Kansas
Forest Investigative Site 074
Prairie Village, Kansas, United States, 66206
United States, Mississippi
Forest Investigative Site 040
Flowood, Mississippi, United States, 39232
United States, Missouri
Forest Investigative Site 068
Creve Coeur, Missouri, United States, 63141
United States, New Jersey
Forest Investigative Site 061
Cherry Hill, New Jersey, United States, 08002
Forest Investigative Site 038
Marlton, New Jersey, United States, 08053
United States, New Mexico
Forest Investigative Site 030
Albuquerque, New Mexico, United States, 87106
United States, New York
Forest Investigative Site 076
Brooklyn, New York, United States, 11235
Forest Investigative Site 037
Mount Kisco, New York, United States, 10549
Forest Investigative Site 067
New York, New York, United States, 10021
Forest Investigative Site 049
New York, New York, United States, 10168
United States, Ohio
Forest Investigative Site 047
Canton, Ohio, United States, 44718
Forest Investigative Site 021
Dayton, Ohio, United States, 45417
United States, Oregon
Forest Investigative Site 022
Portland, Oregon, United States, 97210
Forest Investigative Site 027
Salem, Oregon, United States, 97301
United States, Pennsylvania
Forest Investigative Site 069
Bridgeville, Pennsylvania, United States, 15017
Forest Investigative Site 025
Philadelphia, Pennsylvania, United States, 19139
Forest Investigative Site 031
Reading, Pennsylvania, United States, 19604
United States, Tennessee
Forest Investigative Site 048
Memphis, Tennessee, United States, 38119
United States, Texas
Forest Investigative Site 024
Austin, Texas, United States, 78731
Forest Investigative Site 020
Dallas, Texas, United States, 75231
Forest Investigative Site 070
Houston, Texas, United States, 77054
Forest Investigative Site 080
San Antonio, Texas, United States, 78229
United States, Utah
Forest Investigative Site 028
Salt Lake City, Utah, United States, 84106
United States, Washington
Forest Investigative Site 032
Bellevue, Washington, United States, 98007
Forest Investigative Site 034
Kirkland, Washington, United States, 98033
Estonia
Forest Investigative Site 203
Tallinn, Estonia, 10614
Forest Investigative Site 201
Tallinn, Estonia, 10617
Forest Investigative Site 206
Tallinn, Estonia, 11615
Forest Investigative Site 205
Tallinn, Estonia, 13517
Forest Investigative Site 204
Tartu, Estonia, 50406
Forest Investigative Site 208
Tartu, Estonia, 50417
Forest Investigative Site 207
Tartu, Estonia, 51014
Forest Investigative Site 202
Võru, Estonia, 65608
Finland
Forest Investigative Site 301
Helsinki, Finland, 100
Forest Investigative Site 302
Helsinki, Finland, 100
Forest Investigative Site 304
Helsinki, Finland, 100
Forest Investigative Site 303
Helsinki, Finland, 40100
Forest Investigative Site 305
Kuopio, Finland, 70110
Forest Investigative Site 308
Oulu, Finland, 90100
Forest Investigative Site 307
Pori, Finland, 28100
Slovakia
Forest Investigative Site 602
Banska Stiavnica, Slovakia, 96901
Forest Investigative Site 603
Bardejov, Slovakia, 08501
Forest Investigative Site 604
Bratislava, Slovakia, 82007
Forest Investigative Site 606
Bratislava, Slovakia, 85101
Forest Investigative Site 601
Michalovce, Slovakia, 7101
Forest Investigative Site 605
Rimavska Sobota, Slovakia, 97901
Forest Investigative Site 607
Rimavska Sobota, Slovakia, 97912
Sweden
Forest Investigative Site 803
Lund, Sweden, 22222
Forest Investigative Site 802
Malmö, Sweden, 21152
Forest Investigative Site 801
Stockholm, Sweden, 17145
Ukraine
Forest Investigative Site 705
Stepanivka, Kherson, Ukraine, 73488
Forest Investigative Site 703
Kharkiv, Ukraine, 61068
Forest Investigative Site 704
Kharkiv, Ukraine, 61068
Forest Investigative Site 702
Kyiv, Ukraine, 02660
Forest Investigative Site 701
Kyiv, Ukraine, 04080
Forest Investigative Site 710
Lugansk, Ukraine, 91045
Forest Investigative Site 709
Odesa, Ukraine, 65014
Forest Investigative Site 706
Vinnytsia, Ukraine, 21005
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
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Study Director: Willie Earley, MD Allergan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01469377     History of Changes
Other Study ID Numbers: RGH-MD-75
First Posted: November 10, 2011    Key Record Dates
Results First Posted: May 1, 2018
Last Update Posted: May 1, 2018
Last Verified: March 2018
Keywords provided by Forest Laboratories:
Major depressive disorder
Depression
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Pathologic Processes
Behavioral Symptoms
Cariprazine
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs