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

Anxiety Disorder Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01546896
• Other study ID #: bsp2010
• Status: Withdrawn
• Phase: Phase 4
• First received: March 2, 2012
• Last updated: May 19, 2015
• Start date: March 2012
• Est. completion date: February 2014

Study information

• Verified date: May 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders

Intervention

Drug:
• buspirone+alprazolam
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
• alprazolam
0.5mg/d

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in depressive symptom scores at 8 weeks		baseline and at 8 weeks	No
Primary	change from baseline in depressive symptom scores at 4 weeks		baseline and at 4 weeks	No
Primary	change from baseline in depressive symptom scores at 1 week		baseline and at 1 week	No
Primary	change from baseline in anxiety symptom scores at 8 weeks		baseline and at 8 weeks	No
Primary	change from baseline in anxiety symptom scores at 4 weeks		baseline and at 4 weeks	No
Primary	change from baseline in anxiety symptom scores at 1 week		baseline and at 1 week	No
Secondary	changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach		baseline and at 8 weeks	No
Secondary	number of participants with adverse events		8 weeks	Yes
Secondary	number of participants with adverse events		4 weeks	Yes
Secondary	number of participants with adverse events		1 week	Yes