virtual darkness as additive treatment in mania

Conditions: Bipolar Disorder; Mania

Summary: 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. 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.

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.

Eligibility criteria:
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

Keywords: bipolar disorder mania blue-blockers virtual darkness therapy actigraphy randomized controlled trial