CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 921 enrolled
Drug / intervention
Threat of shockdevice
Likely dose
Not stated in record
Key inclusion· 3
  • Diagnosis of anxiety disorder (GAD, SAD, panic disorder, or specific phobia) or mood disorder (MDD or bipolar disorder) for patients
  • Able to give written informed consent
  • Speaks English fluently
Key exclusion· 9
  • Current alcohol or substance abuse
  • History of alcohol or substance dependence within 6 months prior to screening
  • Currently pregnant
  • History of psychotic disorder or bipolar disorder (for healthy controls); past history of psychotic disorder or bipolar disorder (for patients with anxiety/mood disorders)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00055224
NCT00055224N/ACompleted

Predictability and Aversive Expectancies in Anxiety and Depressive Disorders

National Institute of Mental Health (NIMH)·interventional·Posted Feb 21, 2003·Updated Jan 9, 2024

In Brief

A clinical study evaluating Threat of shock for Anxiety Disorders. Completed, enrolled 921 participants across 1 site.

Detailed 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....

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 21, 2003
Enrollment StartMar 24, 2003
Primary CompletionMar 11, 2020
Study CompletionJul 28, 2022
TodayJul 2, 2026
Enrollment to primary: 17.0 yearsPosted 23.4 years ago

Interventions

Threat of shockdevice

During threat, a participant could receive a shock. During safe, a participant could not receive as shock. Participants selected their highest tolerable level of shock.