Effects of Buspar on Depressive Symptom Improvement and Neuroprotection in Patients With Anxiety Disorder
This study is currently recruiting participants.
Verified March 2012 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
Information provided by (Responsible Party):
In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01546896
First received: March 2, 2012
Last updated: March 7, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety Disorder |
Drug: buspirone+alprazolam Drug: alprazolam Other: healthy controls |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- change from baseline in depressive symptom scores at 8 weeks [ Time Frame: baseline and at 8 weeks ] [ Designated as safety issue: No ]
- change from baseline in depressive symptom scores at 4 weeks [ Time Frame: baseline and at 4 weeks ] [ Designated as safety issue: No ]
- change from baseline in depressive symptom scores at 1 week [ Time Frame: baseline and at 1 week ] [ Designated as safety issue: No ]
- change from baseline in anxiety symptom scores at 8 weeks [ Time Frame: baseline and at 8 weeks ] [ Designated as safety issue: No ]
- change from baseline in anxiety symptom scores at 4 weeks [ Time Frame: baseline and at 4 weeks ] [ Designated as safety issue: No ]
- change from baseline in anxiety symptom scores at 1 week [ Time Frame: baseline and at 1 week ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach [ Time Frame: baseline and at 8 weeks ] [ Designated as safety issue: No ]
- number of participants with adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- number of participants with adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- number of participants with adverse events [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 93 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
| No Intervention: healthy controls |
Other: healthy controls
no intervention
|
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546896
Contacts
| Contact: Junghyun H Lee, MD, MS | 82-10-3453-1744 | leejunghyun1@gmail.com |
Locations
| Korea, Republic of | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Jeong-Hwa Hong, MD 82-2-740-8096 jhhong@snu.ac.kr | |
Sponsors and Collaborators
Seoul National University Hospital
Investigators
| Principal Investigator: | In Kyoon Lyoo, MD, PhD, MMS | Seoul National University Hospital |
More Information
No publications provided
| Responsible Party: | In Kyoon Lyoo, MD, PhD, MMS, Professor, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01546896 History of Changes |
| Other Study ID Numbers: | bsp2010 |
| Study First Received: | March 2, 2012 |
| Last Updated: | March 7, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Alprazolam Buspirone Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Receptor Agonists Serotonin Agents |
ClinicalTrials.gov processed this record on May 23, 2013