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

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.

Study Overview

• Status: Withdrawn
• Conditions: Anxiety Disorder
• Intervention / Treatment: Drug: buspirone+alprazolam; Drug: alprazolam

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: healthy controls
Experimental: buspirone+alprazolam	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
Active Comparator: alprazolam	Drug: alprazolam; 0.5mg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from baseline in depressive symptom scores at 8 weeks	baseline and at 8 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 4 weeks	baseline and at 4 weeks
change from baseline in anxiety symptom scores at 1 week	baseline and at 1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
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	8 weeks
number of participants with adverse events	4 weeks
number of participants with adverse events	1 week

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: March 2, 2012
• First Submitted That Met QC Criteria: March 2, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Estimate): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 19, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Receptor Agonists; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Buspirone; Alprazolam
• Other Study ID Numbers: bsp2010