Phase 4
N=32
Drug Treatment Validation of Functional Magnetic Resonance Imaging in Generalized Anxiety Disorder
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00662259 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Signal Change in Brain Activity in the Amygdala When Viewing Emotional Faces — .1489; .1074; .0119; .1404 Percent signal change in brain acitivity
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Alprazolam (Xanax) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Signal Change in Brain Activity in the Amygdala When Viewing Emotional Faces |
.1489; .1074; .0119; .1404; .1230; .1699 | — |
| PRIMARY Signal Change in Brain Activity in the Insula When Anticipating the Viewing of Emotional Pictures. |
.0707; .0724; .0458; .0645; .0596; .0461 | — |
| SECONDARY Score on the Hamilton Anxiety Scale |
27.79; 28.00; 13.58; 22.18; 10.85; 20.18 | — |
| SECONDARY Score on the Penn State Worry Scale |
64.74; 66.73; 50.26; 62.45; 48.11; 61.36 | — |
Summary
The purpose of this study is to find out how an anti-anxiety drug or placebo affects the activity of your brain when you are at rest and when you are viewing emotional material, such as, emotional faces and pictures.
Eligibility Criteria
Inclusion Criteria
- Male or female between 18 - 65 years of age, inclusive
- In good general health (as determined by medical history, physical examination, laboratory assessments and electrocardiogram (ECG)), especially no findings (including concomitant medications) that would constitute contraindications for treatment with alprazolam
- Diagnostic and Statistical Manual-IV criteria for Generalized Anxiety Disorder (GAD) (exception: at least 3 months of symptoms)
- Hamilton Anxiety Scale at screening >/= 20
- Montgomery-Asberg Depression Rating Scale (MADRS) at screening 10 cigarettes/day); habitual caffeine consumption of more than 400 mg/d (approximately 4 cups of coffee or equivalent)
- Body mass index > 32.5 kg/m2
- Contraindication to magnetic resonance imaging based on a standard fMRI screening forms
- Concurrent participation in an institutional review board (IRB) approved investigational drug trial
- Any other reason why, per clinician, the patient should not participate in this study (to be included in this assessment are all considerations, warnings, precautions as per current FDA-approved drug label for Xanax®)
Data sourced from ClinicalTrials.gov (NCT00662259). 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.