NCT01818622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

3 years

First QC Date

March 22, 2013

Last Update Submit

March 18, 2015

Conditions

Bipolar DisorderMania

Keywords

Bipolar disorderManiaBlue-blockersVirtual darkness therapyActigraphyRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change in motor activity measured by use of actigraphy, Actiwatch Spectrum device

    Change in motor activity over 7 days ( patients) or 14 days ( non-bipolar controls) .

Other Outcomes (3)

  • For the non-bipolar control-group: self report forms Mood Visual Analog Scale, Positive And Negative Affect Schedule and Sleep Diary

    14 days

  • Self-report form for patient's experience.

    At discharge

  • Self report form for non-bipolar controls on experience with intervention

    At end of intervention, day 14

Study Arms (3)

Patient-group blue-blockers

EXPERIMENTAL

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

Patient group clear-lensed goggles

PLACEBO COMPARATOR

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

Device: Clear-lensed goggles

Non-bipolar control-group blue-blockers

EXPERIMENTAL

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

Interventions

Blue-blocking goggles/screensDEVICE

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.

Also known as: Goggles from LowBlueLights.com, several different designs, Screens from Ganta Trading 047 Orange-red
Non-bipolar control-group blue-blockersPatient-group blue-blockers
Clear-lensed gogglesDEVICE

Clear lensed safety eyewear. Patients may choose model for best comfort.

Also known as: Uvex Genesis, Cocraft Safety Glasses 40-7362, 3M Refine 300 PC AS/AF
Patient group clear-lensed goggles

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Written informed consent
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haugesund Hospital and Haugaland District Psychiatric Hospital

Haugesund, 5521, Norway

Location

Valen Hospital and Folgfonn District Hospital

Valen, 5451, Norway

Location

Related Publications (5)

  • 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.

    PMID: 17637502BACKGROUND

  • 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.

    PMID: 17351786BACKGROUND

  • 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.

    PMID: 11487664BACKGROUND

  • 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.

    PMID: 15713707BACKGROUND

  • 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.

    PMID: 16842544BACKGROUND

MeSH Terms

Conditions

Bipolar DisorderMania

Interventions

Early Detection of Cancer

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Early DiagnosisDiagnosis

Study Officials

  • Anders Lund, PhD

    University of Bergen, Moodnet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Consultant

Study Record Dates

First Submitted

March 22, 2013

First Posted

March 26, 2013

Study Start

February 1, 2012

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

NO(2)