Status:
UNKNOWN
Bright Light Therapy in the Treatment of Non-seasonal Bipolar Depression
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Bipolar Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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, diabetes, herpes, etc.).
- Photosensitive treatment, including the following treatments:
- Cyclins (Vibramycin®, Doxycycline®)
- Amiodarone (Cordarone®, Amiodarone®)
- Phenothiazines (Largactil®, Modecate®, Nozinan®, Melleril®, Trilafon®)
- Methotrexate (Methotrexate®)
- Sulfamides (antibiotics, diuretics or hypoglycemic agents)
- Chloroquine (Nivaquine®)
- Some anti-inflammatories (Apranax®, Indocid®)
- Psoralens used in puvatherapy
- Isotretinoin (Roaccutane® and generics)
- Verteporfin (Visudyne®).
- Lactating or pregnant women (pregnancy urine positive test).
- Subjects who have already used light therapy in the last 6 months.
- Therapeutic resistance of the current major depressive episode (≥2 traditional antidepressants such as SSRI, IRSNA, MAOI or tricyclic, at effective therapeutic dosage for more than 6 weeks)
- Use of another antidepressant strategy than the mood stabilizer, including antidepressants of all classes (which will have to be stopped before the initiation of light therapy) and psychotherapy with onset \<1 month.
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03396744
Start Date
September 30 2019
End Date
January 1 2021
Last Update
February 10 2020
Active Locations (1)
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1
Fenand Widal hospital
Paris, France, 75010