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NCT05136690 · ClinicalTrials.gov registry record · Phase 1
Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT05136690: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT05136690 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05136690, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
The primary purpose of this randomized, double-blind, placebo-controlled cross-over study was to record and measure 40 Hz-auditory steady-state response (ASSR) in healthy controls (HC) and participants with mild-to-moderate schizophrenia (SZ) to determine if the mean inter-trial coherence (ITC) magnitude derived from the 40 Hz-ASSR is lower in SZ than in HC at baseline.
Primary Outcome
The ITC magnitude derived from the 40Hz ASSR is presented. ASSR is measured following a short stream of click trains with a 500 msec inter-train interval (duration), at standard tone and at 40Hz tone. The magnitude of ITC represents the phase consistency of oscillatory activities, in response to EEG coherence at 40Hz stimulation. ITC as a unit of measure is expressed as frequency (40Hz) vs time (msec).
Interventions
- DRUG Nicotine patch
- DRUG Placebo capsule
- DRUG Placebo patch
- DRUG MK-4334
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2022-04-27 |
| Est. Completion | 2022-11-04 |
| Phase | Phase 1 |
What the finished NCT05136690 record still lists
NCT05136690 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 4 interventions - of which Nicotine patch is the first listed.
NCT05136690 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05136690 about?
NCT05136690 is a clinical study titled "Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)". The primary purpose of this randomized, double-blind, placebo-controlled cross-over study was to record and measure 40 Hz-auditory steady-state response (ASSR) in healthy controls (HC) and participants with mild-to-moderate schizophrenia (SZ) to determine if the mean inter-trial coherence (ITC) magn...
What is the current status of trial NCT05136690?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2022-04-27. Estimated completion is 2022-11-04.
What interventions are being tested in trial NCT05136690?
The interventions under investigation include: Nicotine patch (DRUG), Placebo capsule (DRUG), Placebo patch (DRUG), MK-4334 (DRUG).
Who is sponsoring clinical trial NCT05136690?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05136690's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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