Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder
Public ClinicalTrials.gov record NCT01469377. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) as Adjunctive Therapy in Major Depressive Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01469377
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 819 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 15, 2011 (Actual)
- Primary completion
- Dec 12, 2013 (Actual)
- Completion
- Dec 12, 2013 (Actual)
- Last update posted
- May 1, 2018
2011 – 2013
United States locations
- U.S. sites
- 39
- U.S. states
- 16
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Forest Investigative Site 077 | Garden Grove | California | 92845 | — |
| Forest Investigative Site 019 | National City | California | 91950 | — |
| Forest Investigative Site 039 | Oceanside | California | 92056 | — |
| Forest Investigative Site 015 | Orange | California | 92868 | — |
| Forest Investigative Site 050 | Orange | California | 92868 | — |
| Forest Investigative Site 008 | Redlands | California | 92374 | — |
| Forest Investigative Site 066 | Sherman Oaks | California | 91403 | — |
| Forest Investigative Site 063 | Gainesville | Florida | 32607 | — |
| Forest Investigative Site 029 | Jacksonville | Florida | 32256 | — |
| Forest Investigative Site 012 | Kissimmee | Florida | 34741 | — |
| Forest Investigative Site 023 | Miami | Florida | 33183 | — |
| Forest Investigative Site 026 | Orlando | Florida | 32806 | — |
| Forest Investigative Site 062 | Atlanta | Georgia | 30328 | — |
| Forest Investigative Site 065 | Smyrna | Georgia | 30080 | — |
| Forest Investigative Site 074 | Prairie Village | Kansas | 66206 | — |
| Forest Investigative Site 040 | Flowood | Mississippi | 39232 | — |
| Forest Investigative Site 068 | Creve Coeur | Missouri | 63141 | — |
| Forest Investigative Site 061 | Cherry Hill | New Jersey | 08002 | — |
| Forest Investigative Site 038 | Marlton | New Jersey | 08053 | — |
| Forest Investigative Site 030 | Albuquerque | New Mexico | 87106 | — |
| Forest Investigative Site 076 | Brooklyn | New York | 11235 | — |
| Forest Investigative Site 037 | Mount Kisco | New York | 10549 | — |
| Forest Investigative Site 067 | New York | New York | 10021 | — |
| Forest Investigative Site 049 | New York | New York | 10168 | — |
| Forest Investigative Site 047 | Canton | Ohio | 44718 | — |
| Forest Investigative Site 021 | Dayton | Ohio | 45417 | — |
| Forest Investigative Site 022 | Portland | Oregon | 97210 | — |
| Forest Investigative Site 027 | Salem | Oregon | 97301 | — |
| Forest Investigative Site 069 | Bridgeville | Pennsylvania | 15017 | — |
| Forest Investigative Site 025 | Philadelphia | Pennsylvania | 19139 | — |
| Forest Investigative Site 031 | Reading | Pennsylvania | 19604 | — |
| Forest Investigative Site 048 | Memphis | Tennessee | 38119 | — |
| Forest Investigative Site 024 | Austin | Texas | 78731 | — |
| Forest Investigative Site 020 | Dallas | Texas | 75231 | — |
| Forest Investigative Site 070 | Houston | Texas | 77054 | — |
| Forest Investigative Site 080 | San Antonio | Texas | 78229 | — |
| Forest Investigative Site 028 | Salt Lake City | Utah | 84106 | — |
| Forest Investigative Site 032 | Bellevue | Washington | 98007 | — |
| Forest Investigative Site 034 | Kirkland | Washington | 98033 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01469377, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 1, 2018 · Synced Oct 27, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01469377 live on ClinicalTrials.gov.