Clinical trial NCT00770068: Examining the Link Between Depression and Seasonal Allergies
Official title: Seasonality of Depression and Airborne Allergens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: Mood Disorders
Major Depressive Disorder
Bipolar Disorder
Tree Pollen
Ragweed Pollen
Rhinitis
Allergic
Seasonal
Allergens
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)
timeFrame: Measured before and then during the peak fall or spring pollen period
Secondary outcomes:
measure: Hypomania Interview Guide (HIGH-SAD)
timeFrame: Measured before and then during the peak fall or spring pollen period
measure: Burns Anxiety Inventory
timeFrame: Measured before and then during the peak fall or spring pollen period
measure: Buss Aggression Questionnaire
timeFrame: Measured before and then during the peak fall or spring pollen period
measure: Allergy Symptom Severity Assessment (ASSA) Questionnaire
timeFrame: Measured before and then during the peak fall or spring pollen period
measure: Serum cytokine, tryptophan (TRP), and kynurenine (KYN) concentrations
timeFrame: Measured before and then during the peak fall or spring pollen period
measure: Nasal secretion test
timeFrame: Measured before and then during the peak fall or spring pollen period
measure: Sleep logs
timeFrame: Measured over 1 week during pre- or post-pollen and peak pollen period
measure: Actiwatch
timeFrame: Measured after the pre-pollen and peak pollen visits for 24 hours a day for 1 week
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Measured during the peak pollen period
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Measured during the peak pollen period
Other outcomes:
Locations:
city: Washington
country: United States
facility: National Center for the Treatment of Phobias, Anxiety, and Depression
state: District of Columbia
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Teodor T. Postolache, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 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.