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Minor11 versionsRe-verified since Aug 22, 2025, no change to tracked fieldsv160-v170
MinorEligibility criteria shortened, about 23 wordsv159
Minor2 versionsRe-verified since Aug 7, 2025, no change to tracked fieldsv157-v158
MinorStudy Status, Study Description, Eligibilityv156
NotableEnrollment target: 40 to 80
Study sites: 1 to 2
v155
Minor5 versionsRe-verified since Mar 19, 2025, no change to tracked fieldsv150-v154
MinorStart date changed from estimate of Mar 2, 2025 to Feb 21, 2025v149
MinorStart date: Feb 27, 2025 to Mar 2, 2025v148
MinorStart date: Feb 26, 2025 to Feb 27, 2025v147
MinorStart date: Feb 25, 2025 to Feb 26, 2025v146
MinorStart date: Feb 24, 2025 to Feb 25, 2025v145
MinorStart date: Feb 23, 2025 to Feb 24, 2025v144
MinorStart date: Feb 20, 2025 to Feb 23, 2025v143
MinorStart date: Feb 19, 2025 to Feb 20, 2025v142
MinorStart date: Feb 18, 2025 to Feb 19, 2025v141
MinorStart date: Feb 17, 2025 to Feb 18, 2025v140
MinorStart date: Feb 16, 2025 to Feb 17, 2025v139
MinorStart date: Feb 13, 2025 to Feb 16, 2025v138
MinorStart date: Feb 12, 2025 to Feb 13, 2025v137
MinorStart date: Feb 11, 2025 to Feb 12, 2025v136
MinorStart date: Feb 10, 2025 to Feb 11, 2025v135
MinorStart date: Feb 9, 2025 to Feb 10, 2025v134
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background:
Irritability can be defined as an unusually strong response to frustration; these responses may include severe temper outbursts and a constant grumpy mood. Irritability is a common symptom of many mental health disorders. Little is known about how the brain responds to frustration, and few treatments are available for this problem. Researchers want to know more about how the brain responds to frustration.
Objective:
To learn how the brain responds to frustration.
Eligibility:
Healthy adults aged 18 to 55 years. They must have been screened through studies 01-M-0254 or 17-M-0181.
Design:
Participants will have up to 3 study visits in 2 months. Each visit will last up to 4 hours.
Visit 1: Participants will be screened. They will have a physical exam. They will complete questionnaires about how often and how easily they get angry or grumpy. They will be trained to use a device that measures hand grip.
Visit 2: Participants will have a magnetic resonance imaging (MRI) scan. They will lie on a table that slides into a tube. Padding will hold their head still.
Visit 3: Participants will undergo magnetoencephalography (MEG). A cone with detectors will be lowered over their head while they are seated. The MEG will measure the magnetic fields in the participant s brain both while they are resting and while they are doing the frustration task. For the task, they will hold a grip device in each hand. They will use the devices to pick 1 of 2 doors on a computer screen. The task has 3 parts. The participant s face will be filmed during this task.