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Virtual Darkness as Additive Treatment in Mania (VATMAN)

Primary Purpose

Bipolar Disorder, Mania

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Blue-blocking goggles/screens
Clear-lensed goggles
Sponsored by
Helse Fonna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar disorder, Mania, Blue-blockers, Virtual darkness therapy, Actigraphy, Randomized controlled trial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Haugesund Hospital and Haugaland District Psychiatric Hospital
  • Valen Hospital and Folgfonn District Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Patient-group blue-blockers

Patient group clear-lensed goggles

Non-bipolar control-group blue-blockers

Arm Description

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.

N= 21 (Patient group) clear-lensed goggles from 06 p.m. to 08 a.m. in addition to TAU.

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).

Outcomes

Primary Outcome Measures

Change in Young Mania Rating Scale (YMRS) score
The YMRS-score is assessed daily at 12 a.m. for 7 days

Secondary Outcome Measures

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)

Full Information

First Posted
March 22, 2013
Last Updated
March 18, 2015
Sponsor
Helse Fonna
Collaborators
University of Bergen, Helse Vest, Moodnet
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1. Study Identification

Unique Protocol Identification Number
NCT01818622
Brief Title
Virtual Darkness as Additive Treatment in Mania
Acronym
VATMAN
Official Title
Virtual Darkness as Additive Treatment in Mania- a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helse Fonna
Collaborators
University of Bergen, Helse Vest, Moodnet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Mania
Keywords
Bipolar disorder, Mania, Blue-blockers, Virtual darkness therapy, Actigraphy, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient-group blue-blockers
Arm Type
Experimental
Arm Description
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.
Arm Title
Patient group clear-lensed goggles
Arm Type
Placebo Comparator
Arm Description
N= 21 (Patient group) clear-lensed goggles from 06 p.m. to 08 a.m. in addition to TAU.
Arm Title
Non-bipolar control-group blue-blockers
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Blue-blocking goggles/screens
Other Intervention Name(s)
Goggles from LowBlueLights.com, several different designs, Screens from Ganta Trading 047 Orange-red
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Clear-lensed goggles
Other Intervention Name(s)
Uvex Genesis, Cocraft Safety Glasses 40-7362, 3M Refine 300 PC AS/AF
Intervention Description
Clear lensed safety eyewear. Patients may choose model for best comfort.
Primary Outcome Measure Information:
Title
Change in Young Mania Rating Scale (YMRS) score
Description
The YMRS-score is assessed daily at 12 a.m. for 7 days
Time Frame
Change from baseline in YMRS score after 7 days
Secondary Outcome Measure Information:
Title
Change in motor activity measured by use of actigraphy, Actiwatch Spectrum device
Description
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)
Time Frame
Change in motor activity over 7 days ( patients) or 14 days ( non-bipolar controls) .
Other Pre-specified Outcome Measures:
Title
For the non-bipolar control-group: self report forms Mood Visual Analog Scale, Positive And Negative Affect Schedule and Sleep Diary
Time Frame
14 days
Title
Self-report form for patient's experience.
Description
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.
Time Frame
At discharge
Title
Self report form for non-bipolar controls on experience with intervention
Description
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
Time Frame
At end of intervention, day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Lund, PhD
Organizational Affiliation
University of Bergen, Moodnet
Official's Role
Study Director
Facility Information:
Facility Name
Haugesund Hospital and Haugaland District Psychiatric Hospital
City
Haugesund
ZIP/Postal Code
5521
Country
Norway
Facility Name
Valen Hospital and Folgfonn District Hospital
City
Valen
ZIP/Postal Code
5451
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
17637502
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.
Results Reference
background
PubMed Identifier
17351786
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.
Results Reference
background
PubMed Identifier
11487664
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.
Results Reference
background
PubMed Identifier
15713707
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.
Results Reference
background
PubMed Identifier
16842544
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.
Results Reference
background

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Virtual Darkness as Additive Treatment in Mania

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