NCT00767754

Brief Summary

Panic disorder is one of the most prevalent and disabling psychiatric disorders. Brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus coeruleus, parahippocampal gyrus, frontal cortex, and thalamus has been reported to be related with the pathophysiology and treatment outcome in panic disorder. Paroxetine has been used as primary agent for treatment of panic disorder but there is little information on how paroxetine affects the brain function in patients with panic disorder. The specific aim of this study is to examine the differences in brain activity between responders and nonresponders and to determine the predictor of paroxetine treatment in patients with panic disorder in terms of brain activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

5 months

First QC Date

October 6, 2008

Last Update Submit

July 21, 2011

Conditions

Panic Disorder

Keywords

panic disorderparoxetinePET

Outcome Measures

Primary Outcomes (1)

  • 18FDG PET, PDSS & HAM-A

    12 weeks

Study Arms (1)

paroxetine cr

OTHER

single arm

Drug: Paxil CR

Interventions

Paxil CRDRUG

12 week treatment of Paxil(20-40mg)

paroxetine cr

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • panic disorder 20-60 years

You may not qualify if:

  • history of major psychosis (schizophrenia or bipolar disorder), social phobia, obsessive-compulsive disorder, and generalized anxiety disorder, and posttraumatic stress disorder, alcohol abuse and dependence, current regular use of benzodiazepines
  • less than 17 on the HAM-D

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Panic Disorder

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bum-Hee Yu, M.D., Ph.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2008

First Posted

October 7, 2008

Study Start

January 1, 2007

Primary Completion

June 1, 2007

Study Completion

December 1, 2008

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations

KR(1)