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

Phase 4

Withdrawn

• Conditions: Anxiety Disorder
• Interventions: Drug: buspirone+alprazolam; Drug: alprazolam

• Registration Number: NCT01546896
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-07
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
buspirone+alprazolam	buspirone+alprazolam	-
alprazolam	alprazolam	-

Primary Outcome Measures

Name	Time	Method
change from baseline in depressive 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 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 1 week	baseline and at 1 week

Secondary Outcome Measures

Name	Time	Method
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	1 week

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of