Examining the Link Between Depression and Seasonal Allergies

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

Study Description

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.

Condition or disease
Depression

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 Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Seasonality of Depression and Airborne Allergens
• Study Start Date: July 15, 2006
• Actual Primary Completion Date: April 11, 2017
• Actual Study Completion Date: April 11, 2017

Groups and Cohorts

Group/Cohort
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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Biospecimen Retention:   Samples Without DNA

Serum

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: 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.

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

Contacts and Locations

Locations

United States, District of Columbia

National Center for the Treatment of Phobias, Anxiety, and Depression

Washington, District of Columbia, United States, 20037

United States, Maryland

University of Maryland

Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

University of Maryland, Baltimore

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Teodor T. Postolache, MD; University of Maryland, Baltimore

More Information

Publications of Results:

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.

Other 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.

• Responsible Party: Teodor Postolache, Professor, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT00770068
• Other Study ID Numbers: R21MH075891 ( U.S. NIH Grant/Contract ); R21MH075891 ( U.S. NIH Grant/Contract ); H26191; DATR A2-AID
• First Posted: October 9, 2008
• Last Update Posted: November 21, 2019
• Last Verified: November 2019

Keywords provided by Teodor Postolache, University of Maryland, Baltimore:

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

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders