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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00770068
Examining the Link Between Depression and Seasonal Allergies
Seasonality of Depression and Airborne Allergens
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20037
- National Center for the Treatment of Phobias, Anxiety, and Depression
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Experimental group
All participants testing positive for tree and ragweed pollen allergies, as determined by levels of immunoglobulin E (IgE) antibodies
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Control group
All participants testing negative for tree and ragweed pollen allergies, as determined by levels of IgE antibodies
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)
Periodo de tiempo: Measured before and then during the peak fall or spring pollen period
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Measured before and then during the peak fall or spring pollen period
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Hypomania Interview Guide (HIGH-SAD)
Periodo de tiempo: Measured before and then during the peak fall or spring pollen period
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Measured before and then during the peak fall or spring pollen period
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Burns Anxiety Inventory
Periodo de tiempo: Measured before and then during the peak fall or spring pollen period
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Measured before and then during the peak fall or spring pollen period
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Buss Aggression Questionnaire
Periodo de tiempo: Measured before and then during the peak fall or spring pollen period
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Measured before and then during the peak fall or spring pollen period
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Allergy Symptom Severity Assessment (ASSA) Questionnaire
Periodo de tiempo: Measured before and then during the peak fall or spring pollen period
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Measured before and then during the peak fall or spring pollen period
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Serum cytokine, tryptophan (TRP), and kynurenine (KYN) concentrations
Periodo de tiempo: Measured before and then during the peak fall or spring pollen period
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Measured before and then during the peak fall or spring pollen period
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Nasal secretion test
Periodo de tiempo: Measured before and then during the peak fall or spring pollen period
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Measured before and then during the peak fall or spring pollen period
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Sleep logs
Periodo de tiempo: Measured over 1 week during pre- or post-pollen and peak pollen period
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Measured over 1 week during pre- or post-pollen and peak pollen period
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Actiwatch
Periodo de tiempo: Measured after the pre-pollen and peak pollen visits for 24 hours a day for 1 week
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Measured after the pre-pollen and peak pollen visits for 24 hours a day for 1 week
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Beck Depression Inventory II (BDI-II)
Periodo de tiempo: Measured during the peak pollen period
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Measured during the peak pollen period
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Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: Measured during the peak pollen period
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Measured during the peak pollen period
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Teodor T. Postolache, MD, University of Maryland, Baltimore
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R21MH075891 (Subvención/contrato del NIH de EE. UU.)
- DATR A2-AID (NIH Adult Translational Research and Treatment Development)
- H26191
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