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

Primary Purpose

Anxiety Disorder

Status
Withdrawn
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
buspirone+alprazolam
alprazolam
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorder

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

buspirone+alprazolam

alprazolam

healthy controls

Arm Description

Outcomes

Primary Outcome Measures

change from baseline in depressive symptom scores at 8 weeks
change from baseline in depressive symptom scores at 4 weeks
change from baseline in depressive symptom scores at 1 week
change from baseline in anxiety symptom scores at 8 weeks
change from baseline in anxiety symptom scores at 4 weeks
change from baseline in anxiety symptom scores at 1 week

Secondary Outcome Measures

changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach
number of participants with adverse events
number of participants with adverse events
number of participants with adverse events

Full Information

First Posted
March 2, 2012
Last Updated
May 19, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01546896
Brief Title
Effects of Buspar on Depressive Symptom Improvement and Neuroprotection in Patients With Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
buspirone+alprazolam
Arm Type
Experimental
Arm Title
alprazolam
Arm Type
Active Comparator
Arm Title
healthy controls
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
buspirone+alprazolam
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
alprazolam
Intervention Description
0.5mg/d
Primary Outcome Measure Information:
Title
change from baseline in depressive symptom scores at 8 weeks
Time Frame
baseline and at 8 weeks
Title
change from baseline in depressive symptom scores at 4 weeks
Time Frame
baseline and at 4 weeks
Title
change from baseline in depressive symptom scores at 1 week
Time Frame
baseline and at 1 week
Title
change from baseline in anxiety symptom scores at 8 weeks
Time Frame
baseline and at 8 weeks
Title
change from baseline in anxiety symptom scores at 4 weeks
Time Frame
baseline and at 4 weeks
Title
change from baseline in anxiety symptom scores at 1 week
Time Frame
baseline and at 1 week
Secondary Outcome Measure Information:
Title
changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach
Time Frame
baseline and at 8 weeks
Title
number of participants with adverse events
Time Frame
8 weeks
Title
number of participants with adverse events
Time Frame
4 weeks
Title
number of participants with adverse events
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In Kyoon Lyoo, MD, PhD, MMS
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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

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