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

Anxiety Disorders Clinical Trial

Official title:

PharmacofMRI of Anxiolytic Medications (Alprazolam)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703885
• Other study ID #: UCSD IRB 060407 - A
• Secondary ID: R01MH075792
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2008
• Last updated: December 19, 2014
• Start date: January 2008
• Est. completion date: August 2008

Study information

• Verified date: December 2014
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Drug:
• 0.25 mg alprazolam
0.25 mg alprazolam PO (liquid) to be administered 1 hour prior to fMRI scan Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
• 1.0 mg alprazolam
1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
• placebo
Placebo (liquid) to be administered 1 hour prior to fMRI scan Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Aupperle RL, Ravindran L, Tankersley D, Flagan T, Stein NR, Simmons AN, Stein MB, Paulus MP. Pregabalin influences insula and amygdala activation during anticipation of emotional images. Neuropsychopharmacology. 2011 Jun;36(7):1466-77. doi: 10.1038/npp.2011.32. Epub 2011 Mar 23. — View Citation

Aupperle RL, Tankersley D, Ravindran LN, Flagan T, Stein NR, Stein MB, Paulus MP. Pregabalin effects on neural response to emotional faces. Front Hum Neurosci. 2012 Mar 27;6:42. doi: 10.3389/fnhum.2012.00042. eCollection 2012. — View Citation

Simmons AN, Arce E, Lovero KL, Stein MB, Paulus MP. Subchronic SSRI administration reduces insula response during affective anticipation in healthy volunteers. Int J Neuropsychopharmacol. 2009 Sep;12(8):1009-20. doi: 10.1017/S1461145709990149. Epub 2009 Jun 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing	Analysis not completed.	Same Day	No
Primary	Voxelwise Brain Imaging Data	Analysis of data not completed.	Post-Rx Administration	No