Anxiety DisordersPhase 4NCT00703885
PharmacofMRI (Functional Magnetic Resonance Imaging) of Anxiolytic Medications (Alprazolam)
A Phase 4 study testing 0.25 mg alprazolam and 1.0 mg alprazolam in people with Anxiety Disorders, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- 0.25 mg alprazolam and 1.0 mg alprazolam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Aug 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92037
About this study
Official title: PharmacofMRI of Anxiolytic Medications (Alprazolam)
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.
Read the 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.
- Conditions
- Anxiety Disorders
- Being tested
- 0.25 mg alprazolam, 1.0 mg alprazolam, placebo
- Keywords
- functional magnetic resonance imaging, fMRI, alprazolam, anxiety disorders
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25 mg alprazolamDrug
Also called Xanax
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 alprazolamDrug
Also called Xanax
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.
placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing
Analysis not completed.
Measured: Same Day
Voxelwise Brain Imaging Data
Analysis of data not completed.
Measured: Post-Rx Administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Murray B. Stein, University of California, San Diego
- Investigators
- Murray B Stein, MD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703885
- Sponsor's protocol ID
- UCSD IRB 060407 - A
- Other IDs
- R01MH075792
- Status last verified
- Dec 2014
- First submitted
- 20 Jun 2008
- Last updated
- 22 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 19545475Aupperle 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.
PubMed 21430645Aupperle 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.
PubMed 22470326
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PharmacofMRI of Anxiolytic Medications (Alprazolam)
- ClinicalTrials.gov ID
- NCT00703885
- Acronym / sponsor ID
- UCSD IRB 060407 - A
- Conditions
- Anxiety Disorders
- Keywords
- functional magnetic resonance imaging, fMRI, alprazolam, anxiety disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 24 Jun 2008 (estimated)
- Results
- Posted 22 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: 0.25 mg alprazolam0.25 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. |
| 2 | Active comparator | Drug: 1.0 mg alprazolam1 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. |
| Placebo | Placebo comparator | Drug: placeboInactive 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.25 mg alprazolamAlso: Xanax0.25 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. | Drug | 1 |
| 1.0 mg alprazolamAlso: Xanax1 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. | Drug | 2 |
| placeboPlacebo (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. | Drug | Placebo |
Primary outcome
Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing
Time frame: Same Day
Analysis not completed.
Voxelwise Brain Imaging Data
Time frame: Post-Rx Administration
Analysis of data not completed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19545475Simmons 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.
- Background: PubMed 21430645Aupperle 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.
- Background: PubMed 22470326Aupperle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murray B Stein, MD, MPH principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.25 mg alprazolam and 1.0 mg alprazolam in people with Anxiety Disorders, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing (time frame: Same Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00703885, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2014.