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Virtual Darkness as Additive Treatment in Mania

NCT01818622 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2015-03-19

No results posted yet for this study

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.

Conditions

Interventions

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.

DEVICE

Clear-lensed goggles

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

Sponsors & Collaborators

  • University of Bergen

    collaborator OTHER

  • Helse Vest

    collaborator OTHER

  • Moodnet

    collaborator UNKNOWN

  • Helse Fonna

    lead OTHER

Principal Investigators

  • Anders Lund, PhD · University of Bergen, Moodnet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-02-28
Completion
2015-03-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01818622 on ClinicalTrials.gov