DepressionNCT00770068
Examining the Link Between Depression and Seasonal Allergies
An observational study of Depression, run by University of Maryland, Baltimore at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depression
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2006to 11 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Diagnosis of major depressive disorder or bipolar disorder
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland
Baltimore, Maryland, 21201
National Center for the Treatment of Phobias, Anxiety, and Depression
Washington D.C., District of Columbia, 20037
About this study
Official title: Seasonality of Depression and Airborne Allergens
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.
Read the 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.
- Conditions
- Depression
- Keywords
- Mood Disorders, Major Depressive Disorder, Bipolar Disorder, Tree Pollen, Ragweed Pollen, Rhinitis, Allergic, Seasonal, Allergens
- Medical subject headings
- Depression, Mood Disorders, Depressive Disorder, Major, Bipolar Disorder, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)
Measured: Measured before and then during the peak fall or spring pollen period
Secondary outcomes (10)
Hypomania Interview Guide (HIGH-SAD)
Measured: Measured before and then during the peak fall or spring pollen period
Burns Anxiety Inventory
Measured: Measured before and then during the peak fall or spring pollen period
Buss Aggression Questionnaire
Measured: Measured before and then during the peak fall or spring pollen period
Allergy Symptom Severity Assessment (ASSA) Questionnaire
Measured: Measured before and then during the peak fall or spring pollen period
Serum cytokine, tryptophan (TRP), and kynurenine (KYN) concentrations
Measured: Measured before and then during the peak fall or spring pollen period
Nasal secretion test
Measured: Measured before and then during the peak fall or spring pollen period
Sleep logs
Measured: Measured over 1 week during pre- or post-pollen and peak pollen period
Actiwatch
Measured: Measured after the pre-pollen and peak pollen visits for 24 hours a day for 1 week
Beck Depression Inventory II (BDI-II)
Measured: Measured during the peak pollen period
Pittsburgh Sleep Quality Index (PSQI)
Measured: Measured during the peak pollen period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study start15 Jul 2006
- Primary completion11 Apr 2017
- Study completion11 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Teodor Postolache, University of Maryland, Baltimore
- Investigators
- Teodor T. Postolache, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770068
- Sponsor's protocol ID
- R21MH075891
- Other IDs
- R21MH075891, H26191, DATR A2-AID
- Status last verified
- Nov 2019
- First submitted
- 8 Oct 2008
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 22329476Postolache 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.
PubMed 18167612
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seasonality of Depression and Airborne Allergens
- ClinicalTrials.gov ID
- NCT00770068
- Acronym / sponsor ID
- R21MH075891
- Conditions
- Depression
- Keywords
- Mood Disorders, Major Depressive Disorder, Bipolar Disorder, Tree Pollen, Ragweed Pollen, Rhinitis, Allergic, Seasonal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Jul 2006
- Primary completion
- 11 Apr 2017 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Diagnosis of major depressive disorder or bipolar disorder
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Background: PubMed 22329476Manalai 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.
- Results publication: PubMed 18167612Postolache 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teodor T. Postolache, MD principal investigator
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00770068, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.