Response of Psychiatric Outpatients to the Great East Japan Earthquake

Mood Disorders Clinical Trial

Official title:

Response of Psychiatric Outpatients to the Great East Japan Earthquake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533064
• Other study ID #: ARCH 8 2012
• Status: Completed
• Phase: N/A
• First received: February 11, 2012
• Last updated: February 14, 2012
• Start date: March 2011
• Est. completion date: May 2011

Study information

• Verified date: February 2012
• Source: Ashikaga Red Cross Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

Description:

Patient progress was determined by whether a change in medication was needed. We focused on psychotropic drug use, including the use of neuroleptics, antidepressants, and benzodiazepines, directly after the disaster on March 11, 2011. Changes in other psychotropic drugs that are prescribed less frequently, such as lithium or anticonvulsants, were not considered in this study. Changes in symptoms that did not require a need to change psychotropic medications were not considered as part of a patient's progress. Physicians rated the relationship between each change in psychotropic drug and the disaster as direct, indirect, or not relevant. Only when three physicians rated the relationship as direct did we consider the change in a patient's progress to be due to the earthquake. Worsening or improvement of symptoms was defined as a change in psychotropic medications as a result of the deterioration or improvement, respectively, of symptoms. The data were stratified by disease category and sex and analyzed using chi-square tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Mood Disorders

Locations

Country	Name	City	State
Japan	Ashikaga Red Cross Hospital	Ashikaga	Tochigi-Prefecture
Japan	Ashikaga Red Cross Hospital	Ashikaga	Tochigi

Sponsors (1)

Lead Sponsor	Collaborator
Ashikaga Red Cross Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient progress determined by whether a change in medication was needed.		2 months after the disaster	No