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Virtual Darkness as Additive Treatment in Mania (VATMAN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01818622
First Posted: March 26, 2013
Last Update Posted: March 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Bergen
Helse Vest
Moodnet
Information provided by (Responsible Party):
Tone Elise Gjoetterud Henriksen, Helse Fonna
  Purpose
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.

Condition Intervention
Bipolar Disorder Mania Device: Blue-blocking goggles/screens Device: Clear-lensed goggles

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Virtual Darkness as Additive Treatment in Mania- a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Tone Elise Gjoetterud Henriksen, Helse Fonna:

Primary Outcome Measures:
  • Change in Young Mania Rating Scale (YMRS) score [ Time Frame: Change from baseline in YMRS score after 7 days ]
    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 [ Time Frame: Change in motor activity over 7 days ( patients) or 14 days ( non-bipolar controls) . ]
    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)


Other Outcome Measures:
  • 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 ]
  • Self-report form for patient's experience. [ Time Frame: At discharge ]
    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.

  • Self report form for non-bipolar controls on experience with intervention [ Time Frame: At end of intervention, day 14 ]
    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


Enrollment: 69
Study Start Date: February 2012
Study Completion Date: March 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Names:
  • Goggles from LowBlueLights.com, several different designs
  • Screens from Ganta Trading 047 Orange-red
Placebo Comparator: Patient group clear-lensed goggles
N= 21 (Patient group) clear-lensed goggles from 06 p.m. to 08 a.m. in addition to TAU.
Device: Clear-lensed goggles
Clear lensed safety eyewear. Patients may choose model for best comfort.
Other Names:
  • Uvex Genesis
  • Cocraft Safety Glasses 40-7362
  • 3M Refine 300 PC AS/AF
Experimental: 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).
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.
Other Names:
  • Goggles from LowBlueLights.com, several different designs
  • Screens from Ganta Trading 047 Orange-red

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01818622


Locations
Norway
Haugesund Hospital and Haugaland District Psychiatric Hospital
Haugesund, Norway, 5521
Valen Hospital and Folgfonn District Hospital
Valen, Norway, 5451
Sponsors and Collaborators
Helse Fonna
University of Bergen
Helse Vest
Moodnet
Investigators
Study Director: Anders Lund, PhD University of Bergen, Moodnet
  More Information

Publications:
Responsible Party: Tone Elise Gjoetterud Henriksen, Chief Consultant, Helse Fonna
ClinicalTrials.gov Identifier: NCT01818622     History of Changes
Other Study ID Numbers: 911678
2011/1668 ( Other Identifier: Regional Ethics Committee North )
First Submitted: March 22, 2013
First Posted: March 26, 2013
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Tone Elise Gjoetterud Henriksen, Helse Fonna:
Bipolar disorder
Mania
Blue-blockers
Virtual darkness therapy
Actigraphy
Randomized controlled trial

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders