Your session is about to expire
← Back to Search
Other
Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)
Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours after patch application on day 1 or day 8
Summary
This trial uses nicotine patches and MK-4334 capsules to study their effects on brain activity in people with mild-to-moderate schizophrenia. The goal is to see if these treatments can help improve brain function in those with schizophrenia. Nicotine has been found to improve cognitive functions in schizophrenia, such as attention and memory.
Eligible Conditions
- Cognitive Impairment
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours after patch application on day 1 or day 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours after patch application on day 1 or day 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Inter-trial Coherence (ITC) Magnitude of 40 Hz-derived Auditory Steady-state Response (ASSR) in HC and SZ Participants at Baseline
Secondary study objectives
Duration Deviant Mismatch Negativity (DD-MMN) in HC and SZ Participants: MMN-A, N100-A, and P3A-A Tests
Duration Deviant Mismatch Negativity (DD-MMN) in HC and SZ Participants: MMN-L, N100-L, and P3A-L Tests
Effect of Nicotine on Mean ITC Magnitude of 40 Hz-derived ASSR in HC and SZ Participants Compared to Baseline
+1 moreSide effects data
From 2020 Phase 4 trial • 1251 Patients • NCT0317678431%
Nausea
27%
Insomnia
16%
Changes in Mood
10%
Skin Rash
6%
Headache
5%
Itching/Hives
100%
80%
60%
40%
20%
0%
Study treatment Arm
Varenicline Only Extended Duration
Varenicline + Patch Standard Duration
Varenicline Only Standard Duration
Varenicline + Patch Extended Duration
Trial Design
2Treatment groups
Experimental Treatment
Group I: Panel B: Participants with Mild-to-Moderate SZExperimental Treatment4 Interventions
In Part 1, participants with mild-to-moderate SZ receive nicotine patch + capsule placebo, and patch placebo + capsule placebo, under a cross-over design in Periods 1 and 2. In Part 2 (Period 3), SZ participants are randomly assigned to receive either MK-4334 250 mg capsule + patch placebo or capsule placebo + patch placebo.
Group II: Panel A: Healthy Control ParticipantsExperimental Treatment4 Interventions
In Part 1, HC participants receive nicotine patch + capsule placebo, and patch placebo + capsule placebo, under a cross-over design in Periods 1 and 2. In Part 2 (Period 3), HC participants are randomly assigned to receive either MK-4334 250 mg capsule + patch placebo or capsule placebo + patch placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine patch
2015
Completed Phase 4
~6130
MK-4334
2022
Completed Phase 1
~40
Placebo patch
2014
Completed Phase 4
~4910
Placebo capsule
2015
Completed Phase 4
~5340
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,450 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,027 Previous Clinical Trials
5,188,765 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,900 Previous Clinical Trials
8,090,396 Total Patients Enrolled