NCT00770068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2017

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

10.7 years

First QC Date

October 8, 2008

Last Update Submit

November 19, 2019

Conditions

Depression

Keywords

Mood DisordersMajor Depressive DisorderBipolar DisorderTree PollenRagweed PollenRhinitisAllergicSeasonalAllergens

Outcome Measures

Primary Outcomes (1)

  • Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)

    Measured before and then during the peak fall or spring pollen period

Secondary Outcomes (10)

  • Hypomania Interview Guide (HIGH-SAD)

    Measured before and then during the peak fall or spring pollen period

  • Burns Anxiety Inventory

    Measured before and then during the peak fall or spring pollen period

  • Buss Aggression Questionnaire

    Measured before and then during the peak fall or spring pollen period

  • Allergy Symptom Severity Assessment (ASSA) Questionnaire

    Measured before and then during the peak fall or spring pollen period

  • Serum cytokine, tryptophan (TRP), and kynurenine (KYN) concentrations

    Measured before and then during the peak fall or spring pollen period

  • +5 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Diagnosis of major depressive disorder or bipolar disorder

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Center for the Treatment of Phobias, Anxiety, and Depression

Washington D.C., District of Columbia, 20037, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Related 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.

    PMID: 22329476BACKGROUND

  • 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.

    PMID: 18167612RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

DepressionMood DisordersDepressive Disorder, MajorBipolar DisorderRhinitis

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersDepressive DisorderBipolar and Related DisordersRespiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Teodor T. Postolache, MD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 9, 2008

Study Start

July 15, 2006

Primary Completion

April 11, 2017

Study Completion

April 11, 2017

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations

US(2)