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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| buspirone+alprazolam | Experimental |
| |
| alprazolam | Active Comparator |
| |
| healthy controls | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| buspirone+alprazolam | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 anxiety symptom scores at 1 week | baseline and at 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach | baseline and at 8 weeks | |
| number of participants with adverse events | 8 weeks |
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Patient Inclusion Criteria:
Healthy Control Subject Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In Kyoon Lyoo, MD, PhD, MMS | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000525 | Alprazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| alprazolam | Drug | 0.5mg/d |
|
| number of participants with adverse events | 4 weeks |
| number of participants with adverse events | 1 week |
| D006571 | Heterocyclic Compounds |