Bipolar Disorder, Mania
Conditions
Keywords
Bipolar disorder, Mania, Blue-blockers, Virtual darkness therapy, Actigraphy, Randomized controlled trial
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.
Interventions
DEVICEBlue-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.
DEVICEClear-lensed goggles
Clear lensed safety eyewear. Patients may choose model for best comfort.
Sponsors
University of Bergen
Helse Vest
Moodnet
Helse Fonna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | 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 |
Countries
Norway
Outcome results
None listed