A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD
Public ClinicalTrials.gov record NCT05414422. 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 Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of Intravenous PCN-101 in Treatment Resistant Depression
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a double-blind, randomized, placebo-controlled, multicenter study comprised of 3 phases:screening (up to 2 weeks \[Day -15 to Day -2\]), In-Clinic Treatment (Day -1 to Day 2; including double-blind treatment \[Day 1\]), and post-treatment follow-up (7 and 14 days after infusion on Days 8 and 15, respectively). A total of 93 adult subjects with TRD will be randomly allocated in equal cohorts of 31 subjects/arm to the 3 arms of the study in a blinded manner.
Study identification
- NCT ID
- NCT05414422
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 102 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
- Jan 31, 2022
- Primary completion
- Nov 9, 2022
- Completion
- Nov 9, 2022
- Last update posted
- Jun 3, 2024
2022
United States locations
- U.S. sites
- 13
- U.S. states
- 7
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Preferred Research Partners | Little Rock | Arkansas | 72211 | — |
| CNS Network | Garden Grove | California | 92845 | — |
| Kadima Neuropsychiatry Institute | La Jolla | California | 92037 | — |
| Synergy San Diego | Lemon Grove | California | 91945 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| Premier Clinical Research Institute Inc. | Miami | Florida | 33122 | — |
| Psych Atlanta | Marietta | Georgia | 30060 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Princeton Medical Institute | Princeton | New Jersey | 08540 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| Neuro-Behavioral Clinical Research | North Canton | Ohio | 44720 | — |
| Insite Clinical Research LLC; Inpatient facility name: Serenity | DeSoto | Texas | 75115 | — |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | — |
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 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05414422, 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 Jun 3, 2024 · Synced Sep 27, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05414422 live on ClinicalTrials.gov.