Study Results
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Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2012-02-29
2015-03-31
Brief Summary
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Detailed Description
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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. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Patient-group blue-blockers
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.
Blue-blocking goggles/screens
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.
Patient group clear-lensed goggles
N= 21 (Patient group) clear-lensed goggles from 06 p.m. to 08 a.m. in addition to TAU.
Clear-lensed goggles
Clear lensed safety eyewear. Patients may choose model for best comfort.
Non-bipolar control-group blue-blockers
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).
Blue-blocking goggles/screens
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.
Interventions
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Blue-blocking goggles/screens
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.
Clear-lensed goggles
Clear lensed safety eyewear. Patients may choose model for best comfort.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Written informed consent
Exclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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University of Bergen
OTHER
Helse Vest
OTHER
Moodnet
UNKNOWN
Helse Fonna
OTHER
Responsible Party
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Tone Elise Gjoetterud Henriksen
Chief Consultant
Principal Investigators
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Anders Lund, PhD
Role: STUDY_DIRECTOR
University of Bergen, Moodnet
Locations
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Haugesund Hospital and Haugaland District Psychiatric Hospital
Haugesund, , Norway
Valen Hospital and Folgfonn District Hospital
Valen, , Norway
Countries
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References
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Phelps J. Dark therapy for bipolar disorder using amber lenses for blue light blockade. Med Hypotheses. 2008;70(2):224-9. doi: 10.1016/j.mehy.2007.05.026. Epub 2007 Jul 16.
Berson DM. Phototransduction in ganglion-cell photoreceptors. Pflugers Arch. 2007 Aug;454(5):849-55. doi: 10.1007/s00424-007-0242-2. Epub 2007 Mar 10.
Brainard GC, Hanifin JP, Greeson JM, Byrne B, Glickman G, Gerner E, Rollag MD. Action spectrum for melatonin regulation in humans: evidence for a novel circadian photoreceptor. J Neurosci. 2001 Aug 15;21(16):6405-12. doi: 10.1523/JNEUROSCI.21-16-06405.2001.
Kayumov L, Casper RF, Hawa RJ, Perelman B, Chung SA, Sokalsky S, Shapiro CM. Blocking low-wavelength light prevents nocturnal melatonin suppression with no adverse effect on performance during simulated shift work. J Clin Endocrinol Metab. 2005 May;90(5):2755-61. doi: 10.1210/jc.2004-2062. Epub 2005 Feb 15.
Sasseville A, Paquet N, Sevigny J, Hebert M. Blue blocker glasses impede the capacity of bright light to suppress melatonin production. J Pineal Res. 2006 Aug;41(1):73-8. doi: 10.1111/j.1600-079X.2006.00332.x.
Other Identifiers
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2011/1668
Identifier Type: OTHER
Identifier Source: secondary_id
911678
Identifier Type: -
Identifier Source: org_study_id
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