Mood DisordersNCT01533064
Response of Psychiatric Outpatients to the Great East Japan Earthquake
An observational study of Mood Disorders, run by Ashikaga Red Cross Hospital at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 11 to 90 years
- Conditions the study is for
- Mood Disorders
- How many people
- 328 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2011to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: a total of 328 psychiatric outpatients of Ashikaga Red Cross Hospital
Who may be able to join
- 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
Who cannot join
- Outpatients who did not consult with our hospital in the 2 months after the earthquake were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mood Disorders
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Psychiatric Outpatients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient progress determined by whether a change in medication was needed.
Measured: 2 months after the disaster
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ashikaga Red Cross Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funayama Michitaka, Ashikaga Red Cross Hospital
- Investigators
- Michitaka Funayama, M.D., Principal investigator, Ashikaga Red Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533064
- Sponsor's protocol ID
- ARCH 8 2012
- Status last verified
- Feb 2012
- First submitted
- 11 Feb 2012
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Psychiatric Outpatients to the Great East Japan Earthquake
- ClinicalTrials.gov ID
- NCT01533064
- Acronym / sponsor ID
- ARCH 8 2012
- Conditions
- Mood Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Ashikaga Red Cross HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Study completion
- May 2011 (actual)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychiatric Outpatients | – | – |
Who may qualify
- Ages
- 11 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- a total of 328 psychiatric outpatients of Ashikaga Red Cross Hospital
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Outpatients who did not consult with our hospital in the 2 months after the earthquake were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient progress determined by whether a change in medication was needed.
Time frame: 2 months after the disaster
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michitaka Funayama, M.D. principal investigator
Ashikaga Red Cross Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Disorders, run by Ashikaga Red Cross Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient progress determined by whether a change in medication was needed. (time frame: 2 months after the disaster). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2012.