Effects of Buspar on Depressive Symptom Improvement and Neuroprotection in Patients With Anxiety Disorder

Study Overview
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Brief Summary
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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.

Conditions
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Anxiety Disorder

Intervention / Treatment
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* Drug: buspirone+alprazolam
* Drug: alprazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: buspirone+alprazolam<br> | Drug: buspirone+alprazolam<br>* 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<br>|
| Active Comparator: alprazolam<br> | Drug: alprazolam<br>* 0.5mg/d<br>|
| No Intervention: healthy controls<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| number of participants with adverse events |  | 4 weeks | 
| number of participants with adverse events |  | 1 week |