NCT03396744

Bright Light Therapy in the Treatment of Non-seasonal Bipolar Depression

Bright Light Therapy in the Treatment of Non-seasonal Bipolar Depressive Episode of Bipolar Disorder: A Dose Research Phase I/II Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Bipolar disorder (BD) is a severe brain disorder characterized by the recurrence of mood episodes. Depressive episodes in BD are frequently refractory and clinicians have few treatment options. Bright light therapy (BLT, also named phototherapy) is a promising emerging antidepressant strategy that is lacking evidence-based guidelines for its prescription in BD, including to avoid side effects such as manic switches. In this context, this study aimed to evaluate modalities of the BLT dosage (time of exposure) escalation depending on the tolerance (manic symptoms) in two groups exposed either during the morning or at mid-day.

Detailed description

Bipolar disorder (BD) is a severe brain disorder characterized by the recurrence of mood episodes. Patients presenting with BD spend more time with depressive symptoms than with manic ones, which have a major impact on the quality of life and is associated with poorer outcomes including recurrences and suicide. In addition depressive phases in BD are frequently refractory and clinicians have few treatment options. Bright light therapy (BLT, also named phototherapy) is the first line treatment for depression with seasonal patterns and show promising results in the treatment of non-seasonal depressions. More evidence in non-seasonal depressions is expected, especially in BD. Moreover, some specificities linked to BD, such as the manic switch, warrant evidence-based therapeutic guidelines and so deserve more studies in BD. Preliminary reports suggest that morning exposure may induce manic switches, and that mid-day exposures may be associated with a decreased risk of manic switch. Different dose-titration protocols have also not been compared, and data are lacking. In this context, this study aimed to evaluate modalities of the BLT dosage (time of exposure) escalation depending on the tolerance (manic symptoms) in two groups exposed either during the morning or at mid-day.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DEVICE	Light	Placebo light (50 Lux) during 1 week and then active bright light with glasses using a dosage escalation (inter- and intra-subject) of 7.5, 10, 15, 30 and 45 min

Timeline

• Start date: 2019-09-30
• Primary completion: 2020-07-01
• Completion: 2021-01-01
• First posted: 2018-01-11
• Last updated: 2020-02-10

Locations

1 site across 1 country: France