CClinicalTrials.gg
CompletedNCT00770068Updated Nov 21, 2019

Examining the Link Between Depression and Seasonal Allergies

An observational study in Depression, sponsored by University of Maryland, Baltimore. Completed at 2 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2019-11-21.

Sponsored by University of Maryland, Baltimore · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depression

Keywords

  • Mood Disorders
  • Major Depressive Disorder
  • Bipolar Disorder
  • Tree Pollen
  • Ragweed Pollen
  • Rhinitis
  • Allergic
  • Seasonal
  • Allergens
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 100 is below the median of 160 across 1,084 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Diagnosis of major depressive disorder or bipolar disorder

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Biospecimen retention
Samples without dna

Groups and 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

06

What researchers measure

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

07

Study locations

2 sites
  • National Center for the Treatment of Phobias, Anxiety, and Depression
    Washington, District of Columbia 20037, United States
  • University of Maryland
    Baltimore, Maryland 21201, United States
08

References and documents

Publications

  • Manalai P, Hamilton RG, Langenberg P, Kosisky SE, Lapidus M, Sleemi A, Scrandis D, Cabassa JA, Rogers CA, Regenold WT, Dickerson F, Vittone BJ, Guzman A, Balis T, Tonelli LH, Postolache TT. Pollen-specific immunoglobulin E positivity is associated with worsening of depression scores in bipolar disorder patients during high pollen season. Bipolar Disord. 2012 Feb;14(1):90-8. doi: 10.1111/j.1399-5618.2012.00983.x. PubMed 22329476 ↗
  • Postolache TT, Lapidus M, Sander ER, Langenberg P, Hamilton RG, Soriano JJ, McDonald JS, Furst N, Bai J, Scrandis DA, Cabassa JA, Stiller JW, Balis T, Guzman A, Togias A, Tonelli LH. Changes in allergy symptoms and depression scores are positively correlated in patients with recurrent mood disorders exposed to seasonal peaks in aeroallergens. ScientificWorldJournal. 2007 Dec 17;7:1968-77. doi: 10.1100/tsw.2007.286. PubMed 18167612 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00770068
Lead sponsor
University of Maryland, Baltimore
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Teodor Postolache (Professor, University of Maryland, Baltimore) — Principal investigator
First posted
Oct 9, 2008
Start date
Jul 15, 2006
Primary completion
Apr 11, 2017
Completion
Apr 11, 2017
Last update
Nov 21, 2019

Study contacts

Teodor T. Postolache, MD
principal investigator · University of Maryland, Baltimore

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion