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Completed

NCT Number: NCT00770068

Examining the Link Between Depression and Seasonal Allergies

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Center for the Treatment of Phobias, Anxiety, and Depression, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Hypomania Interview Guide (HIGH-SAD)

    Time frame: Measured before and then during the peak fall or spring pollen period

  2. Burns Anxiety Inventory

    Time frame: Measured before and then during the peak fall or spring pollen period

  3. Buss Aggression Questionnaire

    Time frame: Measured before and then during the peak fall or spring pollen period

  4. Allergy Symptom Severity Assessment (ASSA) Questionnaire

    Time frame: Measured before and then during the peak fall or spring pollen period

  5. Serum cytokine, tryptophan (TRP), and kynurenine (KYN) concentrations

    Time frame: Measured before and then during the peak fall or spring pollen period

  6. Nasal secretion test

    Time frame: Measured before and then during the peak fall or spring pollen period

  7. Sleep logs

    Time frame: Measured over 1 week during pre- or post-pollen and peak pollen period

  8. Actiwatch

    Time frame: Measured after the pre-pollen and peak pollen visits for 24 hours a day for 1 week

  9. Beck Depression Inventory II (BDI-II)

    Time frame: Measured during the peak pollen period

  10. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Measured during the peak pollen period

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Seasonality of Depression and Airborne Allergens

Important dates

Study start
2006
Primary completion
2017
Study completion
2017
First posted
Oct 9, 2008
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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