Virtual Darkness as Additive Treatment in Mania

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Virtual Darkness as Additive Treatment in Mania- a Randomized Controlled Trial

Conditions
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Bipolar Disorder, Mania

Intervention / Treatment
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* Device: Blue-blocking goggles/screens
* Device: Clear-lensed goggles


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient-group blue-blockers<br>N= 21 Blue-blocking goggles/screens from 6 p.m. to 08 a.m. in addition to treatment as usual (TAU). The goggles may be taken of when going to bed and turning of the light. For consenting patients who are unable to use goggles according to the protocol blue-blocking screens covering light-sources will be used. | Device: Blue-blocking goggles/screens<br>* Goggles with amber tinted lenses, all model's transmittance spectra are identical. Goggles and screens are tested at Department of Physics and Technology, University of Bergen. Patients and non-bipolar controls choose model for best comfort.<br>* Other names: Screens from Ganta Trading 047 Orange-red;|
| Placebo Comparator: Patient group clear-lensed goggles<br>N= 21 (Patient group) clear-lensed goggles from 06 p.m. to 08 a.m. in addition to TAU. | Device: Clear-lensed goggles<br>* Clear lensed safety eyewear. Patients may choose model for best comfort.<br>* Other names: 3M Refine 300 PC AS/AF;|
| Experimental: Non-bipolar control-group blue-blockers<br>N= 42 For baseline day 1-7: Actiwatch Spectrum worn at the wrist of dominant hand, day 8-14 continued wearing of Actiwatch spectrum + blue-blocking goggles from 6 p.m. to 08 a.m. In addition to selfreport forms described in the outcome section self report forms Horne-Ostberg Morningness-Eveningness Questionaire (HOMEQ)and Seasonal Pattern Assessment Questionaire (SPAQ). | Device: Blue-blocking goggles/screens<br>* Goggles with amber tinted lenses, all model's transmittance spectra are identical. Goggles and screens are tested at Department of Physics and Technology, University of Bergen. Patients and non-bipolar controls choose model for best comfort.<br>* Other names: Screens from Ganta Trading 047 Orange-red;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Young Mania Rating Scale (YMRS) score | The YMRS-score is assessed daily at 12 a.m. for 7 days | Change from baseline in YMRS score after 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in motor activity measured by use of actigraphy, Actiwatch Spectrum device | Patient-groups wear Actiwatch Spectrum for 7 days. Non-bipolar controls wear Actiwatch Spectrum for 14 days (day 1-7 for baseline, day 8-14 with intervention) | Change in motor activity over 7 days ( patients) or 14 days ( non-bipolar controls) . | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar disorder, Mania, Blue-blockers, Virtual darkness therapy, Actigraphy, Randomized controlled trial