NCT00088738

Brief Summary

This study is designed to observe the effects of a panic attack in patients with panic disorders and to demonstrate the involvement of Substance P in panic disorder, and thereby, further our understanding of its role in this illness. We will measure levels of Substance P in the brain by obtaining pictures of the brain using PET and MRI....

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2004

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2004

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2008

Completed
Last Updated

July 2, 2017

Status Verified

September 10, 2008

First QC Date

July 30, 2004

Last Update Submit

June 30, 2017

Conditions

Keywords

TachykininAnxietyNeuroreceptorInternalizationCarbon DioxideHealthy VolunteerHVPanic Disorder

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Adults ages 18-50

You may not qualify if:

  • History of psychiatric disease, substance dependence or traumatic brain injury, severe systemic disease, poor vision or hearing
  • History of substance abuse within 6 months
  • Abnormal laboratory tests, including HIV test
  • Any prior participation in other research protocols involving radiation exposure within the past year
  • Prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits. Limits: A total effective dose 2.5 rem in a year and 2.5 rad per year to the lens of the eyes, gonads and blood-forming organs; and 7.5 rad annually for all other organs.
  • Pregnancy and Breast Feeding.
  • Positive HIV test
  • Ages 18-50
  • Male or Female
  • Informed consent given
  • Subjects who regularly consume caffeinated beverages.
  • DSM-IV Axis I diagnostic criteria such as history of, or current Dx ADHD, mood/anxiety disorder, alcohol or psychoactive substance abuse/dependence
  • Psychotropic medication or other drugs that may cross the blood brain barrier
  • Traumatic brain injury, severe systemic disease
  • Abnormal MRI other than minor atrophy
  • +54 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Kramer MS, Cutler N, Feighner J, Shrivastava R, Carman J, Sramek JJ, Reines SA, Liu G, Snavely D, Wyatt-Knowles E, Hale JJ, Mills SG, MacCoss M, Swain CJ, Harrison T, Hill RG, Hefti F, Scolnick EM, Cascieri MA, Chicchi GG, Sadowski S, Williams AR, Hewson L, Smith D, Carlson EJ, Hargreaves RJ, Rupniak NM. Distinct mechanism for antidepressant activity by blockade of central substance P receptors. Science. 1998 Sep 11;281(5383):1640-5. doi: 10.1126/science.281.5383.1640.

    PMID: 9733503BACKGROUND
  • Stockmeier CA, Shi X, Konick L, Overholser JC, Jurjus G, Meltzer HY, Friedman L, Blier P, Rajkowska G. Neurokinin-1 receptors are decreased in major depressive disorder. Neuroreport. 2002 Jul 2;13(9):1223-7. doi: 10.1097/00001756-200207020-00031.

    PMID: 12151774BACKGROUND
  • Deguchi K, Antalffy BA, Twohill LJ, Chakraborty S, Glaze DG, Armstrong DD. Substance P immunoreactivity in Rett syndrome. Pediatr Neurol. 2000 Apr;22(4):259-66. doi: 10.1016/s0887-8994(00)00120-x.

    PMID: 10788742BACKGROUND

MeSH Terms

Conditions

Panic DisorderAnxiety Disorders

Interventions

(2-fluoromethoxy-5-(5-trifluoromethyltetrazol-1-yl)benzyl)(2-phenylpiperidin-3-yl)amine

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 30, 2004

First Posted

August 2, 2004

Study Start

July 27, 2004

Study Completion

September 10, 2008

Last Updated

July 2, 2017

Record last verified: 2008-09-10

Locations