A Phase 1/2 interventional study of Light in Bipolar Depression, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-10.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 1/2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Photosensitive treatment, including the following treatments:
Exposition at 8 a.m +/- 30 min, during 10 active weeks, and assessed 6 months after this intervention
Device: Light
Exposition at 8 a.m +/- 30 min, during 10 active weeks, and assessed 6 months after this intervention.
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
Change in Mania Score
The Young Mania Rating Scale (YMRS) will be used as a measure of tolerance reflecting change in YMRS total scores at each week over the 10 weeks (Total score ≥ 12 defining an hypomanic switch).
Time frame: 10 weeks
Change in Depression Score
The Montgomery-Asberg Depression Rating Scale (MADRS) will be used as a measure of efficacy reflecting changes from baseline to endpoint
Time frame: 6, 8 and 10 weeks
Change in Clinical Global Impressions (CGI)
The Clinical Global Impressions (CGI) will be used as a measure of efficacy reflecting changes from baseline to endpoint
Time frame: 6, 8 and 10 weeks
Change in tolerance
YMRS will be used to evaluate hypomanic switch at 3 days after each duration of exposition change
Time frame: 1, 2, 3, 4, 5, 6, 8 and 10 weeks
Acceptability
measured by auto-questionnaire made by the investigators
Time frame: 1, 2, 3, 4, 5, 6, 8 and 10 weeks
MADRS
The MADRS will be used to evaluate changes of depressive symptoms from baseline
Time frame: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then at 6 months
Clinical Global Impressions (CGI).
Time frame: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months
Quick Inventory of Depressive Symptomatology (QIDS SR-16)
Time frame: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months
Altman Self-Rating Mania Scale (ASRM).
Time frame: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months
Pittsburgh Sleep Quality Index (PSQI).
Time frame: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months
Composite Scale of Morningness (CSM).
Time frame: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months
Circadian Type Inventory (CTI).
Time frame: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months
Epworth Sleepiness Scale (ESS).
Time frame: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months
Side effects: PRISE-M
Time frame: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris