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

NCT00703885 | Completed Phase 4 Results

• 2 other identifiers: UCSD IRB 060407 - AR01MH075792
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety Disorders

Keywords

functional magnetic resonance imaging; fMRI; alprazolam; anxiety disorders

Outcome Measures

Primary Outcomes (2)

• Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing

  Analysis not completed.

  Same Day

• Voxelwise Brain Imaging Data

  Analysis of data not completed.

  Post-Rx Administration

Study Arms (3)

1

ACTIVE COMPARATOR

0.25 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan. One-time, single dose. Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.

Drug: 0.25 mg alprazolam

2

ACTIVE COMPARATOR

1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan One-time, single dose. Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.

Drug: 1.0 mg alprazolam

Placebo

PLACEBO COMPARATOR

Inactive ingredient in liquid matching appearance and volume of the two active alprazolam dose comparators. Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.

Drug: placebo

Interventions

0.25 mg alprazolam DRUG

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.

Also known as: Xanax

1

1.0 mg alprazolam DRUG

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.

Also known as: Xanax

2

placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92037, United States

Location

Related Publications (3)

• 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.

  PMID: 19545475 BACKGROUND

• 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.

  PMID: 21430645 BACKGROUND

• 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.

  PMID: 22470326 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Alprazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

This is a single dose cross-over study in 16 healthy subjects. BOLD fMRI analyses for this study were not completed by the investigators.

Results Point of Contact

• Title: Murray B. Stein MD, MPH
• Organization: UCSD

mstein@ucsd.edu

858-534-6451

Study Officials

• Murray B Stein, MD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2008
• First Posted: June 24, 2008
• Study Start: January 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 22, 2014
• Results First Posted: December 22, 2014

Record last verified: 2014-12

Locations

US (1)