Clinical Trial on Depression - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Depression

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- District of Columbia
  - Washington, District of Columbia, United States, 20037
    - National Center for the Treatment of Phobias, Anxiety, and Depression
- Maryland
  - Baltimore, Maryland, United States, 21201
    - University of Maryland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Measured before and then during the peak fall or spring pollen period

Secondary Outcome Measures

Outcome Measure	Time Frame
Hypomania Interview Guide (HIGH-SAD) Time Frame: Measured before and then during the peak fall or spring pollen period	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	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	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	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	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	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	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	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	Measured during the peak pollen period
Pittsburgh Sleep Quality Index (PSQI) Time Frame: Measured during the peak pollen period	Measured during the peak pollen period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: Teodor T. Postolache, MD, University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 15, 2006

Primary Completion (Actual)

April 11, 2017

Study Completion (Actual)

April 11, 2017

Study Registration Dates

First Submitted

October 8, 2008

First Submitted That Met QC Criteria