Bright Light Therapy in the Treatment of Non-seasonal Bipolar Depression (NCT03396744) | Clinical Trial Compass
UnknownPhase 1/2
Bright Light Therapy in the Treatment of Non-seasonal Bipolar Depression
France45 participantsStarted 2019-09-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must be aged from 18 to 55 year-old.
* Patients must read and understand French language, and must provide written informed consent.
* Patients must be inpatients or outpatients followed in psychiatry for a major depressive episodes.
* Patients must have a diagnosis of bipolar disorder, type I or II, according to the DSM-5 and determined by a SCID.
* Patients must have a major depressive episode, at least of moderate intensity, according to the DSM-5, with a MADRS total score ≥20 and determined by a SCID.
* Patients must have a mood stabilizer since at least 4 weeks at standard dosage (lithium, or sodium valproate, or second generation antipsychotics such as quetiapine, aripiprazole, olanzapine).
* Female patients must be using a medically accepted means of contraception.
* Patients must be affiliated to the social security scheme.
Exclusion Criteria:
* Patients under guardianship or deprivation of liberty by administrative or judicial decision
* Seasonal pattern of major depressive episode according to DSM-5 criteria.
* Psychotic, mixed, or catatonic characteristics according to DSM-5 criteria
* High suicidal risk assessed by the Columbia Scale of Suicide Risk Severity (C-SSRS)
* Not stabilized comorbidities (addictive disorders according to the DSM-5 criteria or other decompensated general medical cause).
* Ophthalmic pathology (cataract, macular degeneration, glaucoma, retinitis pigmentosa) and diseases affecting the retina (retinopathy, d…