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

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Seoul National University

Status and phase

Withdrawn
Phase 4

Conditions

Anxiety Disorder

Treatments

Drug: alprazolam
Drug: buspirone+alprazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT01546896
bsp2010

Details and patient eligibility

About

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.

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 3 patient groups

buspirone+alprazolam
Experimental group
Treatment:
Drug: buspirone+alprazolam
alprazolam
Active Comparator group
Treatment:
Drug: alprazolam
healthy controls
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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