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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00770068
Examining the Link Between Depression and Seasonal Allergies
Seasonality of Depression and Airborne Allergens
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20037
- National Center for the Treatment of Phobias, Anxiety, and Depression
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- University of Maryland
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Hypomania Interview Guide (HIGH-SAD)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Measured during the peak pollen period
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Measured during the peak pollen period
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Teodor T. Postolache, MD, University of Maryland, Baltimore
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R21MH075891 (Sovvenzione/contratto NIH degli Stati Uniti)
- DATR A2-AID (NIH Adult Translational Research and Treatment Development)
- H26191
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .