PharmacofMRI (Functional Magnetic Resonance Imaging) of Anxiolytic Medications (Alprazolam)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Murray B. Stein, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00703885
First received: June 20, 2008
Last updated: December 28, 2011
Last verified: December 2011
  Purpose

The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy controls to examine the acute effects of certain anxiolytic medications on brain function.


Condition Intervention Phase
Anxiety Disorders
Drug: alprazolam
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: PharmacofMRI of Anxiolytic Medications (Alprazolam)

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • To evaluate the effect of an anxiolytic drug versus placebo on brain activity at rest and during emotional stimuli using fMRI [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effects of an anxiolytic drug versus placebo on eye blink startle response at rest and during emotional stimuli (anxiety potentiated startle, APS) as well as on clinical scales [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Alprazolam 0.25 mg PO (liquid) will be administered 1 hour prior to fMRI scan
Drug: alprazolam
alprazolam 0.25 mg PO (liquid) to be administered 1 hour prior to fMRI scan
Other Name: Xanax
Active Comparator: 2
Alprazolam 1 mg PO (liquid) will be administered 1 hour prior to fMRI scan
Drug: alprazolam
Alprazolam 1 mg PO (liquid) will be administered 1 hour prior to fMRI scan
Other Name: Xanax
Placebo Comparator: Placebo Drug: placebo
Placebo (liquid) to be administered 1 hour prior to fMRI scan

Detailed Description:

Increased amygdala and insula activity have been implicated in neurobiological models of anxiety. Using fMRI, the anxiolytic medication, lorazepam, has previously been found to decrease activation in these areas during the processing of emotional stimuli. This study aims to replicate those results but by using a different medication, alprazolam. An eventual aim of this study, in combination with future studies, is to evaluate the utility of fMRI as a tool to identify anxiolytic function in both established and novel compounds that may be used to treat anxiety.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male, or female (not pregnant or intending to become pregnant during the study)
  • Between the ages of 18-30.
  • In good general health.
  • No specific contraindications to the drug being administered

Exclusion Criteria:

  • Subjects with a history of DSM-IV depressive disorder, psychotic disorder, anxiety disorder
  • Subjects who meet criteria for substance abuse or dependence within the last 6 months
  • Subjects with an positive urine screen for illicit drugs
  • having clinically significant abnormal laboratory, ECG or physical examination findings not resolved by the baseline visit
  • Patients who have taken psychotropic drugs or antidepressants (including monoamine oxidase inhibitors, MAOI's) within the last year
  • subject is left-handed.
  • The subject suffers from claustrophobia, or phobia for injections or blood.
  • Magnetic Resonance Imaging related exclusion criteria: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), subjects who have ever been a metal worker/welder; history of eye surgery/eyes washed out because of metal, aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, subjects who are in the first trimester of pregnancy, subjects with an I.U.D. (birth control device), a shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit).
  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: NCT00703885

Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Murray B Stein, MD, MPH University of California, San Diego
  More Information

No publications provided

Responsible Party: Murray B. Stein, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00703885     History of Changes
Other Study ID Numbers: UCSD IRB 060407 - A
Study First Received: June 20, 2008
Last Updated: December 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
functional magnetic resonance imaging
fMRI
alprazolam
anxiety disorders

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014