Virtual Darkness as Additive Treatment in Mania (VATMAN)
Bipolar Disorder, Mania
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
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
Experimental
Placebo Comparator
Experimental
Patient-group blue-blockers
Patient group clear-lensed goggles
Non-bipolar control-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.
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).