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Response of Psychiatric Outpatients to the Great East Japan Earthquake

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Funayama Michitaka, Ashikaga Red Cross Hospital
ClinicalTrials.gov Identifier:
NCT01533064
First received: February 11, 2012
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition
Mood Disorders

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Response of Psychiatric Outpatients to the Great East Japan Earthquake

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ashikaga Red Cross Hospital:

Primary Outcome Measures:
  • Patient progress determined by whether a change in medication was needed. [ Time Frame: 2 months after the disaster ] [ Designated as safety issue: No ]

Enrollment: 328
Study Start Date: March 2011
Study Completion Date: May 2011
Groups/Cohorts
Psychiatric Outpatients

Detailed 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.

  Eligibility

Ages Eligible for Study:   11 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

a total of 328 psychiatric outpatients of Ashikaga Red Cross Hospital

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533064

Locations
Japan
Ashikaga Red Cross Hospital
Ashikaga, Tochigi-Prefecture, Japan, 326-0842
Ashikaga Red Cross Hospital
Ashikaga, Tochigi, Japan, 326-0842
Sponsors and Collaborators
Ashikaga Red Cross Hospital
Investigators
Principal Investigator: Michitaka Funayama, M.D. Ashikaga Red Cross Hospital
  More Information

No publications provided

Responsible Party: Funayama Michitaka, Department of Neuropsychiatry, Ashikaga Red Cross Hospital, Ashikaga Red Cross Hospital
ClinicalTrials.gov Identifier: NCT01533064     History of Changes
Other Study ID Numbers: ARCH 8 2012
Study First Received: February 11, 2012
Last Updated: February 14, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013