Cognitive vs. Emotional Psychopharmacological Manipulations of Fear vs. Anxiety

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT02153944
First received: May 31, 2014
Last updated: August 6, 2016
Last verified: June 2016
  Purpose

Background:

Stress and anxiety can interfere with how well people perform tasks. But performing a task can sometimes lessen anxiety by distracting people from the stress. Researchers want to examine the interaction between attention and stress. They will use two drugs with different effects on stress and concentration.

Objective:

- To better understand how thinking and emotion affect anxiety and performance. Also, to study the effects of methylphenidate and propranolol on performance.

Eligibility:

- Adults age 18 50.

Design:

  • First, participants will be screened with a test in which they hear loud, sudden noises through headphones. Sticky pad electrodes will be placed on the skin under one eye. These electrodes will tell us how sensitive participants are to the noises.
  • Second, participants will complete questionnaires about their mood, thinking, and anxiety. They will give a saliva sample. For this, a cotton swab will be placed in their mouth for 2 minutes.
  • Third, participants will take a single dose of one of the study pills or a placebo. They will then look at words, shapes, and letters on a computer monitor. They will answer questions about what they remember. They may receive a shock or hear loud noises during the tests.
  • For the shocks, small metal disk or sticky pad electrodes will be taped to a wrist or finger. For recording bodily responses, additional electrodes will be placed on the arms, body, and under each eye.
  • Blood pressure and pulse will be measured during the tests. More saliva samples will be taken.
  • At the end of the study, participants will answer questions about their reaction to the study testing and about any effects they noticed from the study pill.
  • After the experiment, participants will be evaluated for effects of the study pill.

Condition Intervention Phase
Anxiety Disorder
Drug: Propanolol
Drug: Methylphenidate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Cognitive vs. Emotional Psycho-Pharmacological Manipulations of Fear vs. Anxiety

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Will the reduction of induced-anxiety with propranolol improve cognitive performance. [ Time Frame: 1year ] [ Designated as safety issue: No ]
  • Will the facilitation of cognitive performance with methylphenidate reduce induced-anxiety. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 159
Study Start Date: May 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Ages 18-50
  • Males and females
  • Subjects give their own consent

EXCLUSION CRITERIA:

  • Clinically significant prior exposure to medications, that based on the investigator s judgment, may impact the study, such as Ritalin (MPH) and Inderal (PRO).
  • Any significant medical or neurological problems (e.g. cardiovascular illness, respiratory illness, neurologic illness, seizure, etc.)
  • Raynaud syndrome
  • IQ < 80
  • Sinus bradycardia (P<50), or tachycardia (P>90)
  • Significant ECG abnormality (i.e., greater than first-degree block etc.)
  • Active broncho-spastic lung disease
  • A history of visits to the emergency room because of asthma, or with recent history of asthma symptoms in the past year, which required medication treatment
  • High or low blood pressure (SBP>140 or SBP<90; SDP<50 or SDP>90)
  • A first-degree family history of mania, schizophrenia, or other psychoses based on verbal reports
  • Significant past psychopathology (e.g., hospitalization for psychiatric disorders, recurrent depression, suicide attempt, psychoses)
  • Current psychiatric disorders according to DSM-IV
  • Past alcohol/drug dependence and alcohol/drug abuse in past one year or lifetime alcohol or drug dependence
  • Current use of psychotropic medication
  • Impaired hearing
  • Pregnancy or positive pregnancy test
  • Neurological syndrome of the wrist (e.g., carpal tunnel syndrome)
  • Breastfeeding
  • Significant lab abnormalities (i.e., CBC with differential, acute care and mineral panel, hepatic panel, thyroid panel)
  • Positive urine toxicology screen
  • You have been in another study with an experimental medication within the previous month
  • Small startle reactivity (a change in EMG activity that is less than 3 times the baseline EMG activity)
  • Glaucoma
  • Current use of anti-acid medications
  • For fMRI participants: Any medical condition that increases risk for fMRI:

    • Any metal implants (clips, screws, plates, pins, etc) or metal fragments cause by injuries or metal working
    • Any sort of medical implants (aneurysm clips, pacemaker, insulin pump, Hickman line, etc.)
    • Permanent eye liner and tattoos above the neck
    • Patients who have difficulty lying flat on their back for up to 90 min in the scanner
    • Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02153944

Contacts
Contact: Monique Ernst, M.D. (301) 402-9355 ernstm@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Monique Ernst, M.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT02153944     History of Changes
Other Study ID Numbers: 140114  14-M-0114 
Study First Received: May 31, 2014
Last Updated: August 6, 2016
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Startle
Induced-Threat
Memory
Stimulant
Cognitive Interference

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Methylphenidate
Propranolol
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on August 29, 2016