Virtual Darkness as Additive Treatment in Mania

Bipolar Disorder Clinical Trial

— VATMAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818622
• Other study ID #: 911678
• Secondary ID: 2011/1668
• Status: Completed
• Phase: N/A
• First received: March 22, 2013
• Last updated: March 18, 2015
• Start date: February 2012
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Helse Fonna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Mania

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Norway	Haugesund Hospital and Haugaland District Psychiatric Hospital	Haugesund
Norway	Valen Hospital and Folgfonn District Hospital	Valen

Sponsors (4)

Lead Sponsor	Collaborator
Helse Fonna	Helse Vest, Moodnet, University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (5)

Berson DM. Phototransduction in ganglion-cell photoreceptors. Pflugers Arch. 2007 Aug;454(5):849-55. Epub 2007 Mar 10. Review. — View 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. — View 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. Epub 2005 Feb 15. — View Citation

Phelps J. Dark therapy for bipolar disorder using amber lenses for blue light blockade. Med Hypotheses. 2008;70(2):224-9. Epub 2007 Jul 16. — View Citation

Sasseville A, Paquet N, Sévigny J, Hébert M. Blue blocker glasses impede the capacity of bright light to suppress melatonin production. J Pineal Res. 2006 Aug;41(1):73-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	For the non-bipolar control-group: self report forms Mood Visual Analog Scale, Positive And Negative Affect Schedule and Sleep Diary		14 days	No
Other	Self-report form for patient's experience.	Self report form developed for the trial for patients experience with the intervention, wearing of Actiwatch Spectrum and general participation in the trial, and section for other comments.	At discharge	No
Other	Self report form for non-bipolar controls on experience with intervention	3 questions: 1)Did you notice any change during the intervention? 2)If yes in question 1)When did you first notice any change? 3)If yes in question 1)Describe the experience in own words	At end of intervention, day 14	No
Primary	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	No
Secondary	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) .	No