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

26 de marzo de 2017 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

10

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Northwestern University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 55 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Dim Light Melatonin Onset from Depression to Remission
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Sleep Schedule from Depression to Remission
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: John Gottlieb, MD, Northwestern University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2011

Finalización primaria (Actual)

1 de diciembre de 2016

Finalización del estudio (Actual)

1 de diciembre de 2016

Fechas de registro del estudio

Enviado por primera vez

29 de enero de 2013

Primero enviado que cumplió con los criterios de control de calidad

2 de febrero de 2013

Publicado por primera vez (Estimar)

5 de febrero de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de marzo de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

26 de marzo de 2017

Última verificación

1 de marzo de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 47709

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Trastorno bipolar

3
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