Clinical trial NCT01546896: Effects of Buspar on Depressive Symptom Improvement and Neuroprotection in Patients With Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Anxiety Disorder
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: change from baseline in depressive symptom scores at 8 weeks
timeFrame: baseline and at 8 weeks
measure: change from baseline in depressive symptom scores at 4 weeks
timeFrame: baseline and at 4 weeks
measure: change from baseline in depressive symptom scores at 1 week
timeFrame: baseline and at 1 week
measure: change from baseline in anxiety symptom scores at 8 weeks
timeFrame: baseline and at 8 weeks
measure: change from baseline in anxiety symptom scores at 4 weeks
timeFrame: baseline and at 4 weeks
measure: change from baseline in anxiety symptom scores at 1 week
timeFrame: baseline and at 1 week
Secondary outcomes:
measure: changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach
timeFrame: baseline and at 8 weeks
measure: number of participants with adverse events
timeFrame: 8 weeks
measure: number of participants with adverse events
timeFrame: 4 weeks
measure: number of participants with adverse events
timeFrame: 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In Kyoon Lyoo, MD, PhD, MMS
role: PRINCIPAL_INVESTIGATOR
References: