CompletedNot Applicable

Expectation of Unpleasant Events in Anxiety Disorders

United States921 participantsStarted 2003-03-24

Plain-language summary

Fear and anxiety are normal responses to a threat. However, anxiety is considered abnormal when the response to the threat is excessive or inappropriate. This study will examine changes in the body and brain that occur during unpleasant learning experiences in healthy volunteers with high, moderate, and low levels of anxiety. A high degree of generalized anxiety is a component of many anxiety disorders and is regarded as a marker of vulnerability for these disorders. People with anxiety disorders and individuals with high degrees of anxiety have inappropriate expectations of unpleasant events. This study will investigate the development of expecting unpleasant events in healthy volunteers with varying degrees of anxiety using aversive conditioning models. A later phase of the study will enroll participants with anxiety disorders and compare their responses to those of healthy volunteers. Patients who meet criteria for an anxiety disorder, and healthy volunteers who have no history of psychiatric or major medical illness will be enrolled in this study. Volunteers will come to the NIH Clinical Center three times for outpatient testing....

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: * Inclusion criteria for both patients and healthy controls * All subjects must be able to give written informed consent prior to participation in this study. * PATIENTS ONLY: May have DSM-IV-TR diagnoses of an anxiety disorder (GAD; SAD; Panic disorder; specific phobia) or mood disorder (MDD; BP). * PATIENTS ONLY: May be taking the mood stabilizers, Depakote or Lithium Carbonate. * Speaks English fluently EXCLUSION CRITERIA: * Exclusion criteria for healthy subjects * Female subjects who are currently pregnant * Subjects who meet DSM-IV criteria for current alcohol or substance abuse * Subjects with a history of alcohol or substance dependence within 6 months prior to screening * Current Axis I psychiatric disorders as identified with the Structured Clinical Interview for DSM-IV-TR axis disorders, non-patient edition (SCID-np). Past history of any psychotic disorder or bipolar disorder. * intelligence quotient (I-Q)\<80 * Medical illnesses (such as diabetes or hypertension) or neurological illnesses (such as carpal tunnel syndrome for shocks to be delivered on affected arm; organic brain impairment; seizure disorder) likely to interfere with the study. * Subjects who are on a medication that may interfere with the study. * Employee of National Institute of Mental Health (NIMH) or an immediate family member who is a NIMH employee. * Exclusion criteria for patients * Patients who would be unable to comply with study procedur…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Percent of Correct Button Presses During Threat Compared to the Safe Condition (AAST)

Timeframe: 2000 ms during trial

Change in Percent of Correct no Button Presses During Threat Compared to the Safe Condition

Timeframe: 2000 ms during trial

Correct-go Reaction Time (RT) - Safe Condition

Timeframe: 2000 ms during trial

Correct-go Reaction Time (RT) - Threat Condition

Timeframe: 2000 ms during trial

Go Correct Hits Followed by Button Press - Safe Condition

Timeframe: 2000 ms during trial

Go Correct Hits Followed by Button Press - Threat Condition

Timeframe: 2000 ms during trial

Nogo Trials Followed by no Button Press - Safe Condition

Timeframe: 2000 ms during trial

Trial details

NCT IDNCT00055224

SponsorNational Institute of Mental Health (NIMH)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2020-03-11

Results submitted2022-12-13

View on ClinicalTrials.gov More Anxiety Disorders trials

Plain-language summary

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Percent of Correct Button Presses During Threat Compared to the Safe Condition (AAST)

Timeframe: 2000 ms during trial

Change in Percent of Correct no Button Presses During Threat Compared to the Safe Condition

Timeframe: 2000 ms during trial

Correct-go Reaction Time (RT) - Safe Condition

Timeframe: 2000 ms during trial

Correct-go Reaction Time (RT) - Threat Condition

Timeframe: 2000 ms during trial

Go Correct Hits Followed by Button Press - Safe Condition

Timeframe: 2000 ms during trial

Go Correct Hits Followed by Button Press - Threat Condition

Timeframe: 2000 ms during trial

Nogo Trials Followed by no Button Press - Safe Condition

Timeframe: 2000 ms during trial