VA Aripiprazole vs Esketamine for Treatment Resistant Depression
Public ClinicalTrials.gov record NCT05554627. 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
VA Aripiprazole vs. Esketamine for Treatment of Depression VAST-D II
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label, parallel-group, randomized clinical trial of up to 6 months treatment of adjunctive intranasal (IN) esketamine (ESK) vs. adjunctive aripiprazole (ARI) in Veterans with unipolar Treatment Resistant Depression (TRD). This study will assess the efficacy, safety, and acceptability of adjunctive IN ESK in comparison to ARI, one of the best studied and most widely used adjunctive therapies for TRD. The primary hypothesis is that participants receiving adjunctive IN ESK will be significantly more likely to achieve remission after six weeks of treatment as compared to those who receive adjunctive ARI. Depressive symptoms will be assessed by central raters (CR), blinded to treatment assignment, using the clinician rated version of the Quick Inventory of Depressive Symptomatology (QIDS-C16), a well-validated tool that is commonly used and is easily translated across other depression inventory scales. The study is powered to detect an absolute difference in remission rates of 10%, or larger, at 6 weeks. Additional outcomes of interest include symptom reduction across 6 months of randomized therapy, side effects and other tolerability indices, attrition rates and measures of quality of life and cost-effectiveness.
Study identification
- NCT ID
- NCT05554627
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 74 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
- Oct 27, 2023 (Actual)
- Primary completion
- Oct 27, 2023 (Actual)
- Completion
- Oct 27, 2023 (Actual)
- Last update posted
- Jan 5, 2024
2023
United States locations
- U.S. sites
- 26
- U.S. states
- 20
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tuscaloosa VA Medical Center, Tuscaloosa, AL | Tuscaloosa | Alabama | 35404 | — |
| Phoenix VA Health Care System, Phoenix, AZ | Phoenix | Arizona | 85012 | — |
| Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR | Little Rock | Arkansas | 72205-5484 | — |
| VA Long Beach Healthcare System, Long Beach, CA | Long Beach | California | 90822 | — |
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1290 | — |
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161 | — |
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045 | — |
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516-2770 | — |
| CERC (VISN1, West Haven, CT) | West Haven | Connecticut | 06516 | — |
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | 30033 | — |
| Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois | 60141-5000 | — |
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana | 46202-2884 | — |
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130 | — |
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417 | — |
| Kansas City VA Medical Center, Kansas City, MO | Kansas City | Missouri | 64128 | — |
| New Mexico VA Health Care System, Albuquerque, NM | Albuquerque | New Mexico | 87108-5153 | — |
| Asheville VA Medical Center, Asheville, NC | Asheville | North Carolina | 28805 | — |
| Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC | Salisbury | North Carolina | 28144 | — |
| Cincinnati VA Medical Center, Cincinnati, OH | Cincinnati | Ohio | 45220 | — |
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106 | — |
| Jackson C. Montgomery VA Medical Center, Muskogee, OK | Muskogee | Oklahoma | 74401 | — |
| Philadelphia MultiService Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19106 | — |
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania | 15240 | — |
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030 | — |
| Salem VA Medical Center, Salem, VA | Salem | Virginia | 24153 | — |
| William S. Middleton Memorial Veterans Hospital, Madison, WI | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05554627, 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 Jan 5, 2024 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05554627 live on ClinicalTrials.gov.