Anxiety Disorder
Conditions
Brief summary
This research aims to investigate the efficacy and safety of buspirone in treating generalized anxiety disorder with depressive symptoms and to evaluate its neuroprotective effects using magnetic resonance imaging.
Interventions
DRUGbuspirone+alprazolam
day 1\ 7: buspirone 10mg/d + alprazolam 0.5mg / day 8\ 28: buspirone 20mg/d + alprazolam 0.5mg / day 29\ 56: buspirone 20\ 30mg/d + alprazolam 0.5mg
DRUGalprazolam
0.5mg/d
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Patient Inclusion Criteria: * Men and women aged between 20 and 65 * Diagnosis of generalized anxiety disorder as assessed by Structured Clinical Interview for DSM-IV (SCID-IV) * Depressive symptom scores measured by Hamilton Depression Rating Scale at screening and baseline assessments: \>=8 and \<=16 Healthy Control Subject Inclusion Criteria * Healthy men and women aged between 20 and 65
Exclusion criteria
* Presence of any major physical or neurological illness (e.g.， head trauma, epilepsy， seizure， stroke， cerebral tumor， multiple sclerosis，cerebrovascular disease， narrow-angle glaucoma， drug hypersensitivity， etc.) * Drug abuse in past 3 months * Contraindications to magnetic resonance imaging (e.g., pacemaker implantation，claustrophobia, etc.) * Diagnosis of any Axis I disorder other than generalized anxiety disorder or presence of symptoms requiring hospitalization * Major depressive episode during past 12 months * Depressive symptom scores measured by Hamilton Depression Rating Scale: \>=17 * Women who are pregnant, breastfeeding, or planning pregnancy * Contraindications to drugs used in the study (e.g., allergy, intolerance, etc.) * Unstable medical illness or severe abnormality in laboratory test at screening assessment * Use of psychoactive medications that may affect brain imaging findings * Intelligence quotient below 80
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from baseline in anxiety symptom scores at 1 week | baseline and at 1 week |
| change from baseline in anxiety symptom scores at 8 weeks | baseline and at 8 weeks |
| change from baseline in anxiety symptom scores at 4 weeks | baseline and at 4 weeks |
| change from baseline in depressive symptom scores at 8 weeks | baseline and at 8 weeks |
| change from baseline in depressive symptom scores at 4 weeks | baseline and at 4 weeks |
| change from baseline in depressive symptom scores at 1 week | baseline and at 1 week |
Secondary
| Measure | Time frame |
|---|---|
| number of participants with adverse events | 8 weeks |
| changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach | baseline and at 8 weeks |
Countries
South Korea
Outcome results
None listed