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Examining the Link Between Depression and Seasonal Allergies

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ClinicalTrials.gov Identifier: NCT00770068
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : November 21, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Teodor Postolache, University of Maryland, Baltimore

Tracking Information
First Submitted Date October 8, 2008
First Posted Date October 9, 2008
Last Update Posted Date November 21, 2019
Study Start Date July 15, 2006
Actual Primary Completion Date April 11, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 8, 2008)
Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD) [ Time Frame: Measured before and then during the peak fall or spring pollen period ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 9, 2008)
  • Hypomania Interview Guide (HIGH-SAD) [ Time Frame: Measured before and then during the peak fall or spring pollen period ]
  • Burns Anxiety Inventory [ Time Frame: Measured before and then during the peak fall or spring pollen period ]
  • Buss Aggression Questionnaire [ Time Frame: Measured before and then during the peak fall or spring pollen period ]
  • Allergy Symptom Severity Assessment (ASSA) Questionnaire [ Time Frame: Measured before and then during the peak fall or spring pollen period ]
  • Serum cytokine, tryptophan (TRP), and kynurenine (KYN) concentrations [ Time Frame: Measured before and then during the peak fall or spring pollen period ]
  • Nasal secretion test [ Time Frame: Measured before and then during the peak fall or spring pollen period ]
  • Sleep logs [ Time Frame: Measured over 1 week during pre- or post-pollen and peak pollen period ]
  • Actiwatch [ Time Frame: Measured after the pre-pollen and peak pollen visits for 24 hours a day for 1 week ]
  • Beck Depression Inventory II (BDI-II) [ Time Frame: Measured during the peak pollen period ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Measured during the peak pollen period ]
Original Secondary Outcome Measures
 (submitted: October 8, 2008)
  • Hypomania Interview Guide (HIGH-SAD) [ Time Frame: Measured before and then during the peak fall or spring pollen period ]
  • Burns Anxiety Inventory [ Time Frame: Measured before and then during the peak fall or spring pollen period ]
  • Buss Aggression Questionnaire [ Time Frame: Measured before and then during the peak fall or spring pollen period ]
  • Allergy Symptom Severity Assessment Questionnaire (ASSA) [ Time Frame: Measured before and then during the peak fall or spring pollen period ]
  • Serum cytokines, TRP, and KYN concentrations [ Time Frame: Measured before and then during the peak fall or spring pollen period ]
  • Nasal secretion test [ Time Frame: Measured before and then during the peak fall or spring pollen period ]
  • Sleep logs [ Time Frame: Measured over 1 week during pre- or post-pollen and peak pollen period ]
  • Actiwatch [ Time Frame: Measured after the pre-pollen and peak pollen visits for 24 hours a day for 1 week ]
  • Beck Depression Inventory II (BDI-II) [ Time Frame: Measured during the peak pollen period ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Measured during the peak pollen period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Examining the Link Between Depression and Seasonal Allergies
Official Title Seasonality of Depression and Airborne Allergens
Brief Summary This study will examine whether spring and fall seasonal depression in individuals with high sensitivity to pollen is linked to seasonal increases in tree and ragweed pollen.
Detailed Description

Those who suffer from depression have their normal lives interrupted by symptoms such as persistent sad thoughts, inability to feel pleasure, and potential suicide. Suicide and depression peak in the spring and fall. Worsening of depression, admission to a hospital for depression and bipolar depression, and use of electroconvulsive therapy for treatment of depression all peak in the spring. Although seasonal affective disorder (SAD), in which depression corresponds with seasonal changes, is commonly associated with the winter subtype, SAD is actually more prevalent as the spring subtype.

Allergies, which also peak in the spring and fall, have been linked to depression. Allergic reactions release cytokines, which are proteins that mediate the immune system response when a foreign substance enters the body. Previous studies have found both that an increase in cytokines in otherwise healthy individuals causes depressive symptoms and that cytokines cause the chemical tryptophan (TRP) to switch from producing serotonin, a neurotransmitter associated with feelings of well-being, to producing kynurenine (KYN), a potentially toxic chemical. To determine whether and to what extent allergies are linked to depression, this study will compare depression levels of participants with and without allergies before and during peak times for seasonal allergies. Results from this study may be used in further research to examine the effects of allergy prevention on depression.

Participants in this study will meet with researchers three times. At the first visit, they will be screened for allergies and give their demographic information. The timing of the second and third visits will depend on each participant's allergies. Those with spring allergies will be tested before and then during the spring allergy season. Those with fall allergies or with no allergies will be tested before and then during the fall allergy season. On the second and third visits questionnaires and clinical interviews will assess depression symptoms, and blood tests will be performed to measure chemical levels of cytokines, TRP, and KYN. During these visits participants will also be asked to complete a sleep log for 1 week. This will entail describing their sleep, activity, caffeine consumption, alcohol consumption, and use of sleep medications. A subgroup will wear an Actiwatch device, which electronically monitors sleep and wakefulness cycles, for 1 week, 24 hours a day.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum
Sampling Method Non-Probability Sample
Study Population A community sample will be recruited via local press and radio advertising. Referrals from mental health providers will be used to supplement this population.
Condition Depression
Intervention Not Provided
Study Groups/Cohorts
  • Experimental group
    All participants testing positive for tree and ragweed pollen allergies, as determined by levels of immunoglobulin E (IgE) antibodies
  • Control group
    All participants testing negative for tree and ragweed pollen allergies, as determined by levels of IgE antibodies
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 10, 2017)
100
Original Estimated Enrollment
 (submitted: October 8, 2008)
250
Actual Study Completion Date April 11, 2017
Actual Primary Completion Date April 11, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of major depressive disorder or bipolar disorder

Exclusion Criteria:

  • Pregnancy or intention to become pregnant within the duration of the study
  • Dependence on alcohol, cocaine, stimulants, benzodiazepines, marijuana, or opiates
  • Major medical illness, including cancer, hepatitis, and autoimmune disease
  • A winter subtype of seasonal affective disorder
  • Diagnosis of psychotic disorder
  • Positive result in Phadiatop allergy test, but negative result in tree or ragweed pollen IgE test
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00770068
Other Study ID Numbers R21MH075891( U.S. NIH Grant/Contract )
R21MH075891 ( U.S. NIH Grant/Contract )
H26191
DATR A2-AID
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Teodor Postolache, University of Maryland, Baltimore
Study Sponsor University of Maryland, Baltimore
Collaborators National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Teodor T. Postolache, MD University of Maryland, Baltimore
PRS Account University of Maryland, Baltimore
Verification Date November 2019