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Circadian Phase in Bipolar Depression: Is it Delayed and Does it Normalize With Remission?

26 mars 2017 mis à jour par: John Gottlieb, Northwestern University
The overall aim of this project is to compare sleep patterns and melatonin profiles in individuals with bipolar disorder during depression and after remission. The hypothesis is that sleep time, rest-activity cycles and melatonin onset will be delayed during depression and become less delayed after remission.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

Bipolar disorder is a prevalent, disabling, and chronic mood disorder characterized by depressive symptoms that alternate with hypomanic, manic or mixed states. The depressive phase of this illness predominates and is associated with cognitive, occupational and social impairment, psychiatric comorbidity, and increased mortality from suicide and general medical problems. Clarification of the pathophysiology of this illness is important to improve treatment effectiveness.

Various lines of evidence suggest that circadian factors play a role in the onset and maintenance of bipolar depression. Rhythmic clinical disturbances are found in the altered sleep-wake cycle, diurnal mood shifts, rest-activity changes, seasonal features, the cyclic pattern of relapse and remission and the polarity inversions that define this disorder. Chronotherapeutic treatments that act by modifying circadian phase have been shown to be effective in ameliorating the depressive symptoms of this illness. In addition to this circumstantial evidence, there is some more direct data implicating circadian dysfunction in bipolar depression. Genetic studies have documented associations between various circadian genes and bipolar illness. Actigraphic studies of activity levels have demonstrated illness-remission differences and phase advances in manic states. Though these latter studies employ more direct assessment methodologies, there are few articles that have attempted to investigate circadian processes in bipolar depression with the use of the core clock processes. These basic clock rhythms include core body temperature, cortisol levels and dim light melatonin onset. Because these physiological oscillations are less influenced by behavior and less prone to masking, they more accurately reflect the intrinsic timing of the central pacemaker.

This study will use dim light melatonin onset and actigraphy to assess the status and changes in circadian phase between states of bipolar depression and their remission. Using a case control methodology, adult subjects will be evaluated during, and after remission from the depressive phase of bipolar disorder.

General Aim

The overall aim of this project is to compare the timing of dim-light melatonin onset and actigraphy-based activity patterns in adult patients with bipolar disorder in depressed vs remitted states. These markers will enable characterization of changes in circadian phase between illness and recovery. A case control design will enable the use of small sample sizes capable of identifying statistically significant changes in the timing of circadian rhythms in the two states of interest.

Hypotheses

It is predicted that the dim light melatonin onset and activity profile will be delayed in the depressed vs. the euthymic state of bipolar disorder. It is further anticipated that this phase delay will lessen when bipolar subjects achieve remission from their depression.

Last, it is predicted that the circadian phase of the dim light melatonin onset and the activity profile will correlate, both being delayed in the depressive phase, and less delayed in euthymia.

Type d'étude

Observationnel

Inscription (Réel)

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Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Illinois
      • Chicago, Illinois, États-Unis, 60611
        • Northwestern University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 55 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adults between 18 and 55 who are currently diagnosed with Bipolar Disorder.

La description

Inclusion Criteria:

  • Ages between 18 and 55
  • Bipolar Disorder Type I or II, with current major depression.
  • Currently receiving active treatment from a psychiatrist for bipolar disorder

Exclusion Criteria:

  • Recent history of, or current Diagnostic and Statistical Manual IV, Text Revision criteria for alcohol or substance abuse/dependence disorders
  • circadian rhythm sleep disorders or sleep apnea
  • current stimulant use
  • any recent or planned transmeridian travel across more than two time zones
  • recent, current, or planned shift work schedules
  • pregnancy or plan to become pregnant
  • a Young Mania Rating Scale Score of greater than or equal to seven
  • received in the past two weeks or plan to receive bright light therapy, dawn simulation, sleep deprivation, or other forms of chronotherapy.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Dim Light Melatonin Onset from Depression to Remission
Délai: Collected at end of first and second weeks of actigraphy.
Subjects will be instructed in the procedures used for home-based, self-collection of saliva samples. The protocol developed by Sit and colleagues at the University of Pittsburgh (attached), will be used. This involves obtaining ten saliva samples, one every 30 minutes, over a 4.5 hour period. This protocol contains instructions about ambient lighting, posture, exercise, eating, and use of the oral swabs and collection kits.
Collected at end of first and second weeks of actigraphy.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Sleep Schedule from Depression to Remission
Délai: One week after initial enrollment and one week after remission of depression.
Wrist actigraphy and sleep logs will be collected for a one week period to estimate the subjects average sleep schedule.
One week after initial enrollment and one week after remission of depression.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: John Gottlieb, MD, Northwestern University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 août 2011

Achèvement primaire (Réel)

1 décembre 2016

Achèvement de l'étude (Réel)

1 décembre 2016

Dates d'inscription aux études

Première soumission

29 janvier 2013

Première soumission répondant aux critères de contrôle qualité

2 février 2013

Première publication (Estimation)

5 février 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 mars 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 mars 2017

Dernière vérification

1 mars 2017

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 47709

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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