Phase 4 Completed N=16 Randomized Single-blind Diagnostic

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

Anxiety

Source: ClinicalTrials.gov NCT00703885 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcomePrimary: Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing	—	—
PRIMARY Voxelwise Brain Imaging Data	—	—

Eligibility 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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00703885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.