Virtual Darkness as Additive Treatment in Mania

Not Applicable

Completed

• Conditions: Bipolar Disorder; Mania
• Interventions: Device: Blue-blocking goggles/screens; Device: Clear-lensed goggles

• Registration Number: NCT01818622
• Lead Sponsor: Helse Fonna

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-03-22
• Study First Submitted QC: 2013-03-22
• Study First Posted: 2013-03-26
• Primary Completion: 2015-02
• Status Verified: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-bipolar control-group blue-blockers	Blue-blocking goggles/screens	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).
Patient group clear-lensed goggles	Clear-lensed goggles	N= 21 (Patient group) clear-lensed goggles from 06 p.m. to 08 a.m. in addition to TAU.
Patient-group blue-blockers	Blue-blocking goggles/screens	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.

Primary Outcome Measures

Name	Time	Method
Change in Young Mania Rating Scale (YMRS) score	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

Name	Time	Method
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) .	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)

Trial Locations

Locations (2)

Valen Hospital and Folgfonn District Hospital; 🇳🇴 Valen, Norway

Haugesund Hospital and Haugaland District Psychiatric Hospital; 🇳🇴 Haugesund, Norway