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NCT02153944 · ClinicalTrials.gov registry record · Phase 4

Cognitive vs. Emotional Psychopharmacological Manipulations of Fear vs. Anxiety

A Phase 4 study of Anxiety Disorder, sponsored by National Institute of Mental Health (NIMH).

Completed
Registry status
Phase 4
Development phase
142
Enrollment target
1
Study location

NCT02153944: Completed Phase 4 study of Anxiety Disorder, sponsored by National Institute of Mental Health (NIMH).

NCT02153944 is a Phase 4 study of Anxiety Disorder that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 142 participants, below the 418-participant average among 20 other Anxiety Disorder trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02153944, a Phase 4 study of Anxiety Disorder, has completed, sponsored by National Institute of Mental Health (NIMH).

COMPLETED
Registry status
Phase 4
Development phase
142 participants
Enrollment target
1
Study location

Study Summary

Objective: The overall aim of this protocol is to examine the effect of pharmacological manipulations of affective and cognitive processes on anxiety and task performance. Ultimately, the goal is 1) to provide insight into the relative influence of cognitive and affective states on anxiety, 2) generate theoretical models that can be applied to a better understanding of the interaction between cognition and emotion, 3) develop a better screening approach to candidate anxiolytics, and 4) help formulate novel therapeutic interventions for clinical anxiety. Excessive or inappropriately sustained anxiety and fear lead to the most common group of psychiatric disorders. A number of theoretical models have been proposed to understand the mechanisms engaged in these maladaptive behaviors. Most recent emphasis has focused on the synergistic contribution of cognitive and emotional processes. Our laboratory has been instrumental in delineating aspects of behavioral and neural processes that are associated with fear and anxiety, using psychophysiological and neuroimaging measures of fear and anxiety. Evidence shows that levels of anxiety modulate cognitive performance, such as working memory or perceptual discrimination, and that, conversely, cognitive engagement influences severity of experimentally induced anxiety. The exact contribution of emotional processes vs. cognitive processes to the experience of anxiety is not clear, similarly to the neural mechanisms underlying these interactions. In this protocol, we propose to manipulate pharmacologically separately cognitive and emotional processes to dissociate their contribution to fear/anxiety, while using state-of-the-art measures of anxiety derived from translational work. Indeed, we already developed integrative experimental models of fear and anxiety via the manipulation of predictable and unpredictable shock, respectively. We already employed successfully these models to measure anxiolytic and anxiogenic effects of vari

Primary Outcome

The magnitude of the startle reflex during working memory tasks (n-back) while undergoing alternating periods of safety and threat of shock. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. The participant holds each stimulus in short-term memory while new stimuli are presented. For each new item presented, the participant's task is to decide if it is the same as the stimulus presented one time before (1Back), two times before (2Back)

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Methylphenidate
  • DRUG Propranolol

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2014-06-16
Est. Completion 2021-10-07
Phase Phase 4

What the finished NCT02153944 record still lists

NCT02153944 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 418-participant average among 20 other Anxiety Disorder trials with a reported enrollment target (66% lower).

The record links to 1 condition, with Anxiety Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT02153944 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT02153944 about?

NCT02153944 is a clinical study titled "Cognitive vs. Emotional Psychopharmacological Manipulations of Fear vs. Anxiety". Objective: The overall aim of this protocol is to examine the effect of pharmacological manipulations of affective and cognitive processes on anxiety and task performance. Ultimately, the goal is 1) to provide insight into the relative influence of cognitive and affective states on anxiety, 2) gene...

What is the current status of trial NCT02153944?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 142 participants. The study started on 2014-06-16. Estimated completion is 2021-10-07.

What conditions does trial NCT02153944 study?

This clinical trial studies the following conditions: Anxiety Disorder.

What interventions are being tested in trial NCT02153944?

The interventions under investigation include: Placebo (DRUG), Methylphenidate (DRUG), Propranolol (DRUG).

Who is sponsoring clinical trial NCT02153944?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02153944 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Anxiety Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02153944's enrollment target sits among peer trials

142 7th of 20 higher than 14 of 20 other Anxiety Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Anxiety Disorder 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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Source: ClinicalTrials.gov NCT02153944, the US trial registry maintained by the National Library of Medicine. NCT02153944 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.