Examining the Link Between Depression and Seasonal Allergies

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00770068
First received: October 8, 2008
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

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
Depression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seasonality of Depression and Airborne Allergens

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hypomania Interview Guide (HIGH-SAD) [ Time Frame: Measured before and then during the peak fall or spring pollen period ] [ Designated as safety issue: Yes ]
  • Burns Anxiety Inventory [ Time Frame: Measured before and then during the peak fall or spring pollen period ] [ Designated as safety issue: No ]
  • Buss Aggression Questionnaire [ Time Frame: Measured before and then during the peak fall or spring pollen period ] [ Designated as safety issue: No ]
  • Allergy Symptom Severity Assessment (ASSA) Questionnaire [ Time Frame: Measured before and then during the peak fall or spring pollen period ] [ Designated as safety issue: No ]
  • Serum cytokine, tryptophan (TRP), and kynurenine (KYN) concentrations [ Time Frame: Measured before and then during the peak fall or spring pollen period ] [ Designated as safety issue: No ]
  • Nasal secretion test [ Time Frame: Measured before and then during the peak fall or spring pollen period ] [ Designated as safety issue: No ]
  • Sleep logs [ Time Frame: Measured over 1 week during pre- or post-pollen and peak pollen period ] [ Designated as safety issue: No ]
  • Actiwatch [ Time Frame: Measured after the pre-pollen and peak pollen visits for 24 hours a day for 1 week ] [ Designated as safety issue: No ]
  • Beck Depression Inventory II (BDI-II) [ Time Frame: Measured during the peak pollen period ] [ Designated as safety issue: Yes ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Measured during the peak pollen period ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 250
Study Start Date: July 2006
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/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

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770068

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
Investigators
Principal Investigator: Teodor T. Postolache, MD University of Maryland, Baltimore County
  More Information

Publications:
Responsible Party: Teodor Postolache, University of Maryland
ClinicalTrials.gov Identifier: NCT00770068     History of Changes
Other Study ID Numbers: R21 MH075891, H26191, DATR A2-AID
Study First Received: October 8, 2008
Last Updated: October 9, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
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

ClinicalTrials.gov processed this record on October 16, 2014