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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Disease
Mental Disorders
Pathologic Processes
Alprazolam
Buspirone
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Receptor Agonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014