Major Depressive Disorder Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) as Adjunctive Therapy in Major Depressive Disorder
Verified date | March 2018 |
Source | Forest Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 819 |
Est. completion date | December 12, 2013 |
Est. primary completion date | December 12, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Estonia | Forest Investigative Site 201 | Tallinn | |
Estonia | Forest Investigative Site 203 | Tallinn | |
Estonia | Forest Investigative Site 205 | Tallinn | |
Estonia | Forest Investigative Site 206 | Tallinn | |
Estonia | Forest Investigative Site 204 | Tartu | |
Estonia | Forest Investigative Site 207 | Tartu | |
Estonia | Forest Investigative Site 208 | Tartu | |
Estonia | Forest Investigative Site 202 | Võru | |
Finland | Forest Investigative Site 301 | Helsinki | |
Finland | Forest Investigative Site 302 | Helsinki | |
Finland | Forest Investigative Site 303 | Helsinki | |
Finland | Forest Investigative Site 304 | Helsinki | |
Finland | Forest Investigative Site 305 | Kuopio | |
Finland | Forest Investigative Site 308 | Oulu | |
Finland | Forest Investigative Site 307 | Pori | |
Slovakia | Forest Investigative Site 602 | Banska Stiavnica | |
Slovakia | Forest Investigative Site 603 | Bardejov | |
Slovakia | Forest Investigative Site 604 | Bratislava | |
Slovakia | Forest Investigative Site 606 | Bratislava | |
Slovakia | Forest Investigative Site 601 | Michalovce | |
Slovakia | Forest Investigative Site 605 | Rimavska Sobota | |
Slovakia | Forest Investigative Site 607 | Rimavska Sobota | |
Sweden | Forest Investigative Site 803 | Lund | |
Sweden | Forest Investigative Site 802 | Malmö | |
Sweden | Forest Investigative Site 801 | Stockholm | |
Ukraine | Forest Investigative Site 703 | Kharkiv | |
Ukraine | Forest Investigative Site 704 | Kharkiv | |
Ukraine | Forest Investigative Site 701 | Kyiv | |
Ukraine | Forest Investigative Site 702 | Kyiv | |
Ukraine | Forest Investigative Site 710 | Lugansk | |
Ukraine | Forest Investigative Site 709 | Odesa | |
Ukraine | Forest Investigative Site 705 | Stepanivka | Kherson |
Ukraine | Forest Investigative Site 706 | Vinnytsia | |
United States | Forest Investigative Site 030 | Albuquerque | New Mexico |
United States | Forest Investigative Site 062 | Atlanta | Georgia |
United States | Forest Investigative Site 024 | Austin | Texas |
United States | Forest Investigative Site 032 | Bellevue | Washington |
United States | Forest Investigative Site 069 | Bridgeville | Pennsylvania |
United States | Forest Investigative Site 076 | Brooklyn | New York |
United States | Forest Investigative Site 047 | Canton | Ohio |
United States | Forest Investigative Site 061 | Cherry Hill | New Jersey |
United States | Forest Investigative Site 068 | Creve Coeur | Missouri |
United States | Forest Investigative Site 020 | Dallas | Texas |
United States | Forest Investigative Site 021 | Dayton | Ohio |
United States | Forest Investigative Site 040 | Flowood | Mississippi |
United States | Forest Investigative Site 063 | Gainesville | Florida |
United States | Forest Investigative Site 077 | Garden Grove | California |
United States | Forest Investigative Site 070 | Houston | Texas |
United States | Forest Investigative Site 029 | Jacksonville | Florida |
United States | Forest Investigative Site 034 | Kirkland | Washington |
United States | Forest Investigative Site 012 | Kissimmee | Florida |
United States | Forest Investigative Site 038 | Marlton | New Jersey |
United States | Forest Investigative Site 048 | Memphis | Tennessee |
United States | Forest Investigative Site 023 | Miami | Florida |
United States | Forest Investigative Site 037 | Mount Kisco | New York |
United States | Forest Investigative Site 019 | National City | California |
United States | Forest Investigative Site 049 | New York | New York |
United States | Forest Investigative Site 067 | New York | New York |
United States | Forest Investigative Site 039 | Oceanside | California |
United States | Forest Investigative Site 015 | Orange | California |
United States | Forest Investigative Site 050 | Orange | California |
United States | Forest Investigative Site 026 | Orlando | Florida |
United States | Forest Investigative Site 025 | Philadelphia | Pennsylvania |
United States | Forest Investigative Site 022 | Portland | Oregon |
United States | Forest Investigative Site 074 | Prairie Village | Kansas |
United States | Forest Investigative Site 031 | Reading | Pennsylvania |
United States | Forest Investigative Site 008 | Redlands | California |
United States | Forest Investigative Site 027 | Salem | Oregon |
United States | Forest Investigative Site 028 | Salt Lake City | Utah |
United States | Forest Investigative Site 080 | San Antonio | Texas |
United States | Forest Investigative Site 066 | Sherman Oaks | California |
United States | Forest Investigative Site 065 | Smyrna | Georgia |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories | Gedeon Richter Ltd. |
United States, Estonia, Finland, Slovakia, Sweden, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline to Week 8 | |
Secondary | 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. | Baseline to Week 8 |
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