VATMANVirtual Darkness as Additive Treatment in Mania- a Randomized Controlled Trial
Blue-blocking goggles/screens
+ Clear-lensed goggles
+ Blue-blocking goggles/screens
Trastornos Bipolares y Relacionados+5
+ Trastornos Mentales
+ Enfermedades del sistema nervioso
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de febrero de 2012
Fecha en la que se inscribió al primer participante.Recent discoveries in neurophysiology has shown that "virtual darkness" is achievable by blocking blue wavelengths of light (Phelps, 2007). A newly discovered retinal photoreceptor called the Intrinsically photoresponsive retinal ganglion-cell (IpRGC) whose fibers directly synapses with the suprachiasmatic nucleus (SCN), responds only to a narrow band of wavelengths with highest sensitivity between 446 and 484 nm (Brainard et al., 2001; Berson 2007). Amber tinted goggles preserve normal nocturnal melatonin levels in light environments, which means that blocking of the blue wavelengths is perceived as virtual darkness to the SCN (Kayumov, 2005; Sasseville, 2006). In this randomized controlled study we will investigate the effect of blue-blocking goggles or screens (virtual darkness therapy) on manic symptoms in bipolar disorder compared to placebo. The general feasibility of the method both in research and treatment will be evaluated. This is a multi-site study covering Helse Fonna Local Health Authority's catchment area wich serves a population of 120000 adults. This 3-armed study includes 2 patient-groups and a non-bipolar control-group. The main hypothesis is that virtual darkness therapy is effective as additive treatment in mania.Other hypotheses are that virtual darkness therapy has significant effects on sleep, motor activity, circadian rhythm and mood also in the non-bipolar control-group. The study may contribute to develop a supplement to the current treatment in mania and may also generate new hypotheses about the underlying pathophysiological mechanisms in bipolar disorder.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 69 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 70 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
PATIENT GROUPS Inclusion Criteria: Inpatients Diagnosis of DSM IV-TR of Bipolar I or Bipolar II disorder with current manic episode as verified by the semistructured interview MINI plus Ability to comply with the protocol Willingness to participate in the study Delayed written informed consent at discharge Exclusion Criteria: Inability to comply with the protocol Severe retinal damage, cataract or corneal damage on both eyes Daily use of NSAIDS Daily use of betablockers Daily use of calcium-antagonists NON-BIPOLAR CONTROLS Inclusion Criteria: Written informed consent Exclusion Criteria: Working night shift Diagnosed with bipolar disorder or single manic episode Severe retinal damage, cataract or corneal damage on both eyes Daily use of alcohol Daily use of benzodiazepines Daily use of NSAIDS Daily use of betablockers Daily use of calcium-antagonists
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.3 grupos de intervención están designados en este estudio
33.333333333333336% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
PlaceboGrupo III
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 2 ubicaciones
Haugesund Hospital and Haugaland District Psychiatric Hospital
Haugesund, NorwayAbrir Haugesund Hospital and Haugaland District Psychiatric Hospital en Google MapsValen Hospital and Folgfonn District Hospital
Valen, Norway