Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02809677
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : March 8, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University at Buffalo
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
The investigators propose a one-year, repeated measures, within-subject design to examine the impact of improved caregiver depression on child asthma outcomes. A cross-lagged panel modeling (CLPM) for longitudinal data will be fit using a maximum likelihood structural equation model (SEM) in order to explore longitudinal mediation between asthma outcomes (asthma control, spirometry, quality of life (QOL)) and depressive symptoms. CLPM will test whether caregiver improvement preceded child asthma improvement, and SEM will test whether improved adherence and/or decreased child anxiety/depression mediated the effect. The investigators considered a randomized control trial, but it would not be ethically acceptable to withhold medication from caregivers diagnosed with Major Depressive Disorder (MDD) for the proposed one-year duration of the study. It is unlikely that potential participants in the study would find this acceptable. Furthermore a controlled design is not necessary since the investigators are not testing the efficacy of antidepressants for depression, but rather the impact of improvement on caregiver depression on the child.

Condition or disease Intervention/treatment Phase
Asthma Major Depressive Disorder Drug: Escitalopram Drug: Venlafaxine XR Drug: Bupropion XR Drug: Sertraline Drug: Mirtazapine Drug: Buspirone Drug: Quetiapine Drug: Aripiprazole Drug: Lithium Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators
Study Start Date : December 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Caregivers

Arm Intervention/treatment
Non-Interventional Longitudinal Study
This is a 52 week non-placebo controlled and non-randomized clinical research study to see whether treating Major Depressive Disorder (MDD) in caregivers of children with asthma will improve asthma outcomes in children. Caregivers may choose to receive an antidepressant medication that is considered standard medical care for MDD, or may opt out of antidepressant treatment. No treatment is withheld from participants and no placebos are used, thus there is no active intervention in this study.
Drug: Escitalopram
Escitalopram (ESC) for the Major Depressive Disorder (MDD). Dose titration schedule: begin at Week 1 at 5mg PO QD for 4 weeks. Increase to 10mg PO QD at Week 4 (if needed). Increase to 20mg PO QD at Week 8 (if needed).
Other Name: Lexapro

Drug: Venlafaxine XR
Venlafaxine Extended Release (VEN XR) for the Major Depressive Disorder (MDD). Dose titration schedule: begin at Week 1 at 75mg PO QD for 4 weeks. Increase at Week 4 to 150mg PO QD (if needed). Increase at Week 8 to 300mg PO QD (if needed).
Other Name: Effexor

Drug: Bupropion XR
Bupropion Extended Release (BUP XR) for the Major Depressive Disorder (MDD). Dose titration schedule: begin at Week 1 at 150mg PO QD for 4 weeks. Increase at Week 4 to 300mg PO QD (if needed). Increase at Week 8 to 450mg PO QD (if needed).
Other Name: Wellbutrin

Drug: Sertraline
Sertraline (SERT) for the Major Depressive Disorder (MDD). Dose titration schedule: begin at Week 1 at 50mg PO QD for 4 weeks. Increase at Week 4 to 100mg PO QD (if needed). Increase at Week 8 to 200mg PO QD (if needed).
Other Name: Zoloft

Drug: Mirtazapine
Mirtazapine (MIRT) for the Major Depressive Disorder (MDD). Dose titration schedule: begin at Week 1 at 15mg PO qHS for 4 weeks. Increase at Week 4 to 30mg PO qHS (if needed). Increase at Week 8 to 45mg PO qHS (if needed).
Other Name: Remeron

Drug: Buspirone

Buspirone (BUSP) as an augmenting agent for the Major Depressive Disorder (MDD).

Dose titration schedule: begin at Week 24 of the study (if needed) at 10mg PO QD for 3 days, then 10mg PO BID for 4 weeks. Increase at Week 28 (if needed) to 15mg PO BID. Increase at Week 32 (if needed) to 20mg PO BID.

Other Name: Buspar

Drug: Quetiapine

Quetiapine (QUET) as an augmenting agent for the Major Depressive Disorder (MDD).

Dose titration schedule: begin at Week 24 of the study (if needed) at 25mg PO qHS for 4 weeks. Increase at Week 28 (if needed) to 50mg PO qHS. Increase at Week 32 (if needed) to 100mg PO qHS.

Other Name: Seroquel

Drug: Aripiprazole
Aripiprazole as an augmenting agent for the Major Depressive Disorder (MDD) for non-response patients at Week 48 of study. Dose titration schedule: begin at Week 48 (if needed) at 2mg PO QD for 4 weeks.
Other Name: Abilify

Drug: Lithium
Lithium as an augmenting agent for the Major Depressive Disorder (MDD) for non-response patients at Week 48 of study. Dose titration schedule: begin at Week 48 (if needed) at 300mg PO qHS for 4 weeks.
Other Name: Lithobid




Primary Outcome Measures :
  1. Change from Baseline in the caregiver's depression scores, as assessed by Hamilton Rating Scale for Depression (HRS-D). [ Time Frame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks. ]
  2. Change from Baseline in the child's asthma control scores, as indicated by increased Asthma Control Test (ACT) scores. [ Time Frame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks. ]
  3. Change from Baseline in the child's asthma control scores, as indicated by decreased Composite Asthma Severity Index (CASI) scores. [ Time Frame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks. ]
  4. Change from Baseline in the caregiver's depression scores, as assessed by Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR). [ Time Frame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks. ]

Secondary Outcome Measures :
  1. Change from Baseline in the number of unscheduled asthma-related service utilization visits for the child participant at 52 weeks. [ Time Frame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks. ]
  2. Change from Baseline in child's quality of life scores on the Pediatric Asthma Quality of Life Questionnaire. [ Time Frame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks. ]
  3. Relationship between caregiver's medication adherence and child depression scorers, as assessed by the Child Depression Inventory (CDI). [ Time Frame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks. ]
  4. Relationship between caregiver's antidepressant medication adherence and child anxiety scorers, as assessed by the Screen for Child Anxiety Disorders (SCARED). [ Time Frame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Caregiver: Male or female, ages 18 to 70, primary asthma caregiver of the child, currently meeting criteria for Major Depressive Disorder (MDD) (based on depression symptoms for at least 2 weeks and causing clinically significant distress or impairment in social, occupational, or other important areas of functioning) based on a Structured Clinical Interview for DSM-4 (SCID) interview.
  • Child: Male or female, ages 7-17 years who have a diagnosis of persistent asthma as classified by either of the following criteria:
  • A. requirement for treatment with daily controller medication; or
  • B. symptoms of persistent asthma in children not on a daily controller medication:
  • 1. Daytime symptoms two or more days per week; or
  • 2. Rescue bronchodilator use two or more times per week; or
  • 3. Nocturnal symptoms two or more nights per month; or
  • 4. Two or more oral steroid bursts in the last year.

Exclusion Criteria:

  • Caregiver: Severe cognitive impairment that could impair their ability to provide informed consent; member of a vulnerable population (incarcerated, pregnant or breastfeeding women); women of childbearing age who will not use acceptable methods of birth control or abstinence during the study; severe psychiatric disorder in addition to MDD that should be a primary focus of treatment (e.g. severe and disabling eating or anxiety disorders); treatment refractory depression defined as failing ≥ 3 adequate trials of antidepressants (≥ 4 weeks at a therapeutic dose); electroconvulsive therapy or repeated transcranial magnetic stimulation during the current episode; depression as part of bipolar disorder or schizophrenia or schizoaffective disorder, or current depression secondary to substances or general medical condition, or with psychotic features or accompanied by severe obsessive compulsive disorder (OCD), or high risk for suicide defined by multiple recent suicide attempts (> 2 in the past year) or any attempt in the past month, or current suicidal ideation with a well-formed plan or intent.
  • Child: Severe cognitive impairment that could impair their ability to provide informed consent; high risk for suicide defined by multiple recent suicide attempts (> 2 in the past year) or any attempt in the past month, or current suicidal ideation with a well-formed plan or intent; severe or life-threatening medical illness, such as other serious cardiopulmonary conditions (e.g. congenital heart disease, cystic fibrosis, alpha-1-antitrypsin disease) or cancer, which would confound the assessment of asthma, anxiety, depression or quality of life; severe psychiatric illness, such as autism, bipolar disorder, schizophrenia or current drug/alcohol abuse/dependence. If an eligible caregiver presents with more than one child meeting inclusion criteria for the study, only one child, randomly selected, will be enrolled.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809677


Contacts
Layout table for location contacts
Contact: Alexandra Kulikova, M.S., M.A. 214-645-6967 alexandra.kulikova@utsouthwestern.edu

Locations
Layout table for location information
United States, Texas
University of Texas Southwestern Medical Center Psychoneuroendocrine Research Program Recruiting
Dallas, Texas, United States, 75235
Contact: Traci Holmes, B.A.    214-645-6959    traci.holmes@utsouthwestern.edu   
Principal Investigator: Edson S Brown, M.D., PhD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
University at Buffalo
Investigators
Layout table for investigator information
Principal Investigator: Edson S Brown, M.D., PhD University of Texas Southwestern Medical Center

Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02809677     History of Changes
Other Study ID Numbers: 022014-069
1R01HL123609-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mood Disorders
Mental Disorders
Dexetimide
Aripiprazole
Quetiapine Fumarate
Lithium Carbonate
Mirtazapine
Buspirone
Citalopram
Bupropion
Venlafaxine Hydrochloride
Sertraline
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents