Clinical trial NCT01818622: Virtual Darkness as Additive Treatment in Mania
Official title: Virtual Darkness as Additive Treatment in Mania- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Mania
Keywords: Bipolar disorder
Mania
Blue-blockers
Virtual darkness therapy
Actigraphy
Randomized controlled trial
Lead sponsor: Helse Fonna
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: Helse Vest
name: Moodnet
First posted: 2013-03-26
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

Primary outcomes:
measure: Change in Young Mania Rating Scale (YMRS) score
timeFrame: Change from baseline in YMRS score after 7 days
Secondary outcomes:
measure: Change in motor activity measured by use of actigraphy, Actiwatch Spectrum device
timeFrame: Change in motor activity over 7 days ( patients) or 14 days ( non-bipolar controls) .
Other outcomes:
measure: For the non-bipolar control-group: self report forms Mood Visual Analog Scale, Positive And Negative Affect Schedule and Sleep Diary
timeFrame: 14 days
measure: Self-report form for patient's experience.
timeFrame: At discharge
measure: Self report form for non-bipolar controls on experience with intervention
timeFrame: At end of intervention, day 14
Locations:
city: Haugesund
country: Norway
facility: Haugesund Hospital and Haugaland District Psychiatric Hospital
city: Valen
country: Norway
facility: Valen Hospital and Folgfonn District Hospital
Study officials:
affiliation: University of Bergen, Moodnet
name: Anders Lund, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.