Phase 4
Completed N=32
Drug Treatment Validation of Functional Magnetic Resonance Imaging in Generalized Anxiety Disorder
Source: ClinicalTrials.gov NCT00662259 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Signal Change in Brain Activity in the Amygdala When Viewing Emotional Faces — .1489; .1074; .0119; .1404 Percent signal change in brain acitivity
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.