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

• Status: Withdrawn
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Alprazolam; Buspirone

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