Depressive Disorder, MajorNCT00223288
Impact of Caregiver Depression on Asthma in the Child
An observational study of Depressive Disorder, Major and Asthma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study will examine if depression in a primary caregiver is associated with more hospitalization or ER visits in children with asthma. This study will also explore whether treatment for depression in the primary caregivers is associated with improvement in asthma in school-aged children. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depressive Disorder, Major, Asthma
- What is being tested?
- Lexapro
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Feb 2006
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Primary caregiver of a child currently hospitalized at Children's Medical Center of Dallas for an asthma exacerbation and between the ages of 5 and 16 years old
Who may be able to join
- Primary caregiver of a child currently hospitalized at Children's Medical Center of Dallas for an asthma exacerbation and between the ages of 5 and 16 years old
- Male and female
- English or Spanish Speaking
- Between the ages of 18 and 70 years old
- Caregivers with major depressive disorder will be offered treatment
Who cannot join
- At risk for suicide defined by multiple suicide attempts (greater than or equal to 3 in the past), and/or current suicidal ideation with a well-formed plan or intent
- Unlikely to attend follow-up appointments
- Mentally retarded or suffer from other severe cognitive impairment
- Pregnant or nursing, or women of childbearing age who will not use methods of birth control or abstinence during the study
- Suffering from a severe or life-threatening medical illness which would make completion of the study unlikely
- Suffering from treatment refractory depression defined by failing three adequate trials of antidepressants
- Depression as part of bipolar disorder or schizophrenia or schizoaffective disorder, or current depression secondary to a medication or general medical condition, or with psychotic features
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
About this study
Official title: Caregiver Psychiatric Symptomatology and it's Relationship to Service Utilization by Children With Asthma
This study will examine if depression in a primary caregiver is associated with more hospitalization or ER visits in children with asthma. This study will also explore whether treatment for depression in the primary caregivers is associated with improvement in asthma in school-aged children.
Asthma is a very common childhood disorder of airway inflammation. The causes include environmental irritants, cold temperature, and infection in the respiratory tract, and emotional factors can contribute to symptom exacerbation. However, asthma is a disease that can be well controlled if there is proper medication compliance and careful control of environmental conditions.
Data suggests that psychiatric symptoms in the mothers of children with asthma are associated with more asthma related hospitalizations in children. Thus, we want to explore this question further using more specific diagnostic instruments in order to detect what types of symptoms are associated with increased asthma related service utilization. Also, we want to explore if effective treatment of the caregivers' symptoms is associated with decreased hospitalization and emergency room visits for the child.
- Conditions
- Depressive Disorder, Major, Asthma
- Being tested
- Lexapro
- Medical subject headings
- Depressive Disorder, Major, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LexaproDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Enrolment
- 175 participants
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- E. Sherwood Brown, MD, Ph.D., Principal investigator, University of Texas, Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223288
- Sponsor's protocol ID
- MHGP MM12
- Status last verified
- Aug 2011
- First submitted
- 15 Sep 2005
- Last updated
- 3 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Psychiatric Symptomatology and it's Relationship to Service Utilization by Children With Asthma
- ClinicalTrials.gov ID
- NCT00223288
- Acronym / sponsor ID
- MHGP MM12
- Conditions
- Depressive Disorder, Major, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 22 Sep 2005 (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.
This study will examine if depression in a primary caregiver is associated with more hospitalization or ER visits in children with asthma. This study will also explore whether treatment for depression in the primary caregivers is associated with improvement in asthma in school-aged children.
Asthma is a very common childhood disorder of airway inflammation. The causes include environmental irritants, cold temperature, and infection in the respiratory tract, and emotional factors can contribute to symptom exacerbation. However, asthma is a disease that can be well controlled if there is proper medication compliance and careful control of environmental conditions.
Data suggests that psychiatric symptoms in the mothers of children with asthma are associated with more asthma related hospitalizations in children. Thus, we want to explore this question further using more specific diagnostic instruments in order to detect what types of symptoms are associated with increased asthma related service utilization. Also, we want to explore if effective treatment of the caregivers' symptoms is associated with decreased hospitalization and emergency room visits for the child.
Study design
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Primary caregiver of a child currently hospitalized at Children's Medical Center of Dallas for an asthma exacerbation and between the ages of 5 and 16 years old
Key inclusion criteria (5 listed)
- Primary caregiver of a child currently hospitalized at Children's Medical Center of Dallas for an asthma exacerbation and between the ages of 5 and 16 years old
- Male and female
- English or Spanish Speaking
- Between the ages of 18 and 70 years old
- Caregivers with major depressive disorder will be offered treatment
Key exclusion criteria (7 listed)
- At risk for suicide defined by multiple suicide attempts (greater than or equal to 3 in the past), and/or current suicidal ideation with a well-formed plan or intent
- Unlikely to attend follow-up appointments
- Mentally retarded or suffer from other severe cognitive impairment
- Pregnant or nursing, or women of childbearing age who will not use methods of birth control or abstinence during the study
- Suffering from a severe or life-threatening medical illness which would make completion of the study unlikely
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lexapro | Drug | – |
Primary outcome
Not reported in the source record.
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 3 Aug 2011.
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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.
E. Sherwood Brown, MD, Ph.D. principal investigator
University of Texas, Southwestern Medical Center at Dallas
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 Depressive Disorder, Major and Asthma, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 5 inclusion and 7 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 3 Aug 2011. 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 United States. 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.
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 3 Aug 2011.