Overview

This trial is active, not recruiting.

Condition depression
Sponsor University of Maryland
Collaborator National Institute of Mental Health (NIMH)
Start date July 2006
End date July 2015
Trial size 250 participants
Trial identifier NCT00770068, DATR A2-AID, H26191, R21 MH075891, R21MH075891

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
All participants testing positive for tree and ragweed pollen allergies, as determined by levels of immunoglobulin E (IgE) antibodies
All participants testing negative for tree and ragweed pollen allergies, as determined by levels of IgE antibodies

Primary Outcomes

Measure
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

Measure
Hypomania Interview Guide (HIGH-SAD)
time frame: Measured before and then during the peak fall or spring pollen period
Burns Anxiety Inventory
time frame: Measured before and then during the peak fall or spring pollen period
Buss Aggression Questionnaire
time frame: Measured before and then during the peak fall or spring pollen period
Allergy Symptom Severity Assessment (ASSA) Questionnaire
time frame: Measured before and then during the peak fall or spring pollen period
Serum cytokine, tryptophan (TRP), and kynurenine (KYN) concentrations
time frame: Measured before and then during the peak fall or spring pollen period
Nasal secretion test
time frame: Measured before and then during the peak fall or spring pollen period
Sleep logs
time frame: Measured over 1 week during pre- or post-pollen and peak pollen period
Actiwatch
time frame: Measured after the pre-pollen and peak pollen visits for 24 hours a day for 1 week
Beck Depression Inventory II (BDI-II)
time frame: Measured during the peak pollen period
Pittsburgh Sleep Quality Index (PSQI)
time frame: Measured during the peak pollen period

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

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

Additional Information

Official title Seasonality of Depression and Airborne Allergens
Principal investigator Teodor T. Postolache, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of Maryland.