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NCT05086250 · ClinicalTrials.gov registry record · Early Phase 1
Feasibility Study of Oral Ketamine Versus Placebo for the Treatment of Anxiety in Patients With Pancreatic Cancer
A Early Phase 1 study of Anxiety and Pancreatic Cancer, sponsored by Cedars-Sinai Medical Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05086250: Recruiting Early Phase 1 study of Anxiety and Pancreatic Cancer, sponsored by Cedars-Sinai Medical Center.
NCT05086250 is a Early Phase 1 study of Anxiety and Pancreatic Cancer that is actively recruiting participants, run by Cedars-Sinai Medical Center. The registered enrollment target is 20 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05086250, a Early Phase 1 study of Anxiety and Pancreatic Cancer, is actively recruiting participants, sponsored by Cedars-Sinai Medical Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective, single center, double blind, randomized, crossover feasibility study of oral ketamine versus placebo for the treatment of anxiety in patients with pancreatic cancer currently receiving or within 12 weeks of receiving cancer targeted therapy. The primary objective is to determine the feasibility of enrolling subjects and treatment adherence. The secondary objectives are to describe the safety and tolerability. Exploratory objectives are to assess the effect of ketamine/placebo on Depression, Anxiety, Physical Function, Pain Interference, Pain Intensity, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities as measured by PROMIS Anxiety Short Form 7a and the PROMIS-29 Profile v2.1 of Patient Reported Outcomes, as well as changes in circulatory inflammatory cytokines, blood glutamine levels, and other biomarkers of anxiety and/or depression.
Primary Outcome
The following will be collected as part of this feasibility measurement: * Reasons for dropout. * Proportion of patients pre-screened that were potentially eligible for study participation. * Proportion of patients that were potentially eligible who were approached. * Proportion of approached patients that decline study participation and why. * Proportion of approached patients that agreed to participate. * Proportion of approached that were randomized. * Proportion of patients completing study
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ketamine
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-10-20 |
| Est. Completion | 2026-12 |
| Phase | Early Phase 1 |
What NCT05086250 shows while recruiting
NCT05086250 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Anxiety appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05086250 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05086250 about?
NCT05086250 is a clinical study titled "Feasibility Study of Oral Ketamine Versus Placebo for the Treatment of Anxiety in Patients With Pancreatic Cancer". This is a prospective, single center, double blind, randomized, crossover feasibility study of oral ketamine versus placebo for the treatment of anxiety in patients with pancreatic cancer currently receiving or within 12 weeks of receiving cancer targeted therapy. The primary objective is to determi...
What is the current status of trial NCT05086250?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2022-10-20. Estimated completion is 2026-12.
What conditions does trial NCT05086250 study?
This clinical trial studies the following conditions: Anxiety, Pancreatic Cancer.
What interventions are being tested in trial NCT05086250?
The interventions under investigation include: Placebo (DRUG), Ketamine (DRUG).
Who is sponsoring clinical trial NCT05086250?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05086250 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05086250's enrollment target sits among peer trials
20 326th of 364 higher than 34 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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