Examining the Link Between Depression and Seasonal Allergies

Depression Clinical Trial

Official title:

Seasonality of Depression and Airborne Allergens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770068
• Other study ID #: R21MH075891
• Secondary ID: R21MH075891H2619
• Status: Completed
• Start date: July 15, 2006
• Est. completion date: April 11, 2017

Study information

• Verified date: November 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 11, 2017
• Est. primary completion date: April 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	National Center for the Treatment of Phobias, Anxiety, and Depression	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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 correla — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)		Measured before and then during the peak fall or spring pollen period
Secondary	Hypomania Interview Guide (HIGH-SAD)		Measured before and then during the peak fall or spring pollen period
Secondary	Burns Anxiety Inventory		Measured before and then during the peak fall or spring pollen period
Secondary	Buss Aggression Questionnaire		Measured before and then during the peak fall or spring pollen period
Secondary	Allergy Symptom Severity Assessment (ASSA) Questionnaire		Measured before and then during the peak fall or spring pollen period
Secondary	Serum cytokine, tryptophan (TRP), and kynurenine (KYN) concentrations		Measured before and then during the peak fall or spring pollen period
Secondary	Nasal secretion test		Measured before and then during the peak fall or spring pollen period
Secondary	Sleep logs		Measured over 1 week during pre- or post-pollen and peak pollen period
Secondary	Actiwatch		Measured after the pre-pollen and peak pollen visits for 24 hours a day for 1 week
Secondary	Beck Depression Inventory II (BDI-II)		Measured during the peak pollen period
Secondary	Pittsburgh Sleep Quality Index (PSQI)		Measured during the peak pollen period