MedDataX Logo

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

NCT ID: NCT01546896

Last Updated: 2015-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

buspirone+alprazolam

Group Type EXPERIMENTAL

buspirone+alprazolam

Intervention Type DRUG

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

alprazolam

Group Type ACTIVE_COMPARATOR

alprazolam

Intervention Type DRUG

0.5mg/d

healthy controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

alprazolam

0.5mg/d

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

In Kyoon Lyoo, MD, PhD, MMS

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

In Kyoon Lyoo, MD, PhD, MMS

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

bsp2010

Identifier Type: -

Identifier Source: org_study_id