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

NCT01546896 | Withdrawn Phase 4 DMC

• 1 other identifier: bsp2010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorder

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• 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

Study Arms (3)

buspirone+alprazolam

EXPERIMENTAL

Drug: buspirone+alprazolam

alprazolam

ACTIVE COMPARATOR

Drug: alprazolam

healthy controls

NO INTERVENTION

Interventions

buspirone+alprazolam 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

buspirone+alprazolam

alprazolam DRUG

0.5mg/d

alprazolam

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Alprazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• In Kyoon Lyoo, MD, PhD, MMS

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 7, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

KR (1)