NCT01533064

Brief Summary

Objective: Reports have described how hospitalized psychiatric patients respond to disasters; however, few reports have described the response to disaster among psychiatric outpatients, who have relatively mild disease in comparison with hospitalized, severely ill psychiatric patients. Here the investigators have analyzed the response to disaster among this under-studied population. Method: The Great East Japan Earthquake on March 11, 2011, was a catastrophic disaster. The investigators studied psychiatric change among a population of psychiatric outpatients in Tochigi prefecture, located \~160 km (\~100 miles) southeast of the Fukushima nuclear power plant, in an area that suffered moderate damage from the earthquake. A total of 328 psychiatric outpatients were enrolled and were grouped into the diagnostic categories F2 (schizophrenic, schizotypal, and delusional disorders), F3 (affective disorders), and F4 (neurotic, stress-related, and somatoform disorders). All diagnoses were made using International Classification of Diseases (ICD) 10 criteria. Changes in symptoms were measured as a change in psychotropic medication after the disaster.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
328

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

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

March 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
Last Updated

February 15, 2012

Status Verified

February 1, 2012

First QC Date

February 11, 2012

Last Update Submit

February 14, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient progress determined by whether a change in medication was needed.

    2 months after the disaster

Study Arms (1)

Psychiatric Outpatients

Eligibility Criteria

Age11 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

a total of 328 psychiatric outpatients of Ashikaga Red Cross Hospital

You may qualify if:

  • Outpatients of Ashikaga Red Cross Hospital before the Great East Japan Earthquake on March 11, 2011 who are classified as F2 (schizophrenic, schizotypal, and delusional disorders), F3 (affective disorders), or F4 (neurotic, stress-related, and somatoform disorders), using International Classification of Diseases (ICD) 10 diagnostic criteria

You may not qualify if:

  • Outpatients who did not consult with our hospital in the 2 months after the earthquake were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ashikaga Red Cross Hospital

Ashikaga, Tochigi, 326-0842, Japan

Location

MeSH Terms

Conditions

Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Michitaka Funayama, M.D.

    Ashikaga Red Cross Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Neuropsychiatry, Ashikaga Red Cross Hospital

Study Record Dates

First Submitted

February 11, 2012

First Posted

February 15, 2012

Study Start

March 1, 2011

Study Completion

May 1, 2011

Last Updated

February 15, 2012

Record last verified: 2012-02

Locations