New treatment option for Depression, Unipolar
Official title BioClock: Bright Light Therapy for Depressive Disorders
ClinicalTrials.gov ID: NCT05958940
What this study is testing
- What it's testing
- Bright Light Therapy (BLT) is a proven treatment for depression in seasonal and non-seasonal depressive disorders, as well as bipolar disorder. To make BLT more effective and practical in clinical settings and tailor it to individual needs, it is necessary to optimize the treatment approach, understand how the treatment works, and identify patient characteristics that predict response.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age between 18 and 65.
- Diagnosis of unipolar or bipolar depression (seasonal or non-seasonal) as assessed with the Mini-International Neuropsychiatric Interview (M.I.N.I.)
- A current depressive episode (a score of 6 or higher on the Quick Inventory of depressive symptomatology Self Report (QIDS-SR)
- Sufficient knowledge of Dutch or English language to fill in questionnaires
- Provided Informed consent
You likely can't join if
- A current (hypo)manic or mixed episode (as assessed with the M.I.N.I.)
- Current psychotic episode (as assessed with the M.I.N.I.)
- Prominent active suicidality (score 10 or higher on the M.I.N.I. module)
- Antidepressant therapy (medication, psychotherapy or BLT, or other forms of specific treatments for depression) that started less than 2 months prior...
- participants with bipolar disorder should be in mood-stabilizing treatment for at least 1 month in a recommended dosage,
- Use of melatonin or agomelatine in the last month
See the full eligibility criteria
- Age between 18 and 65.
- Diagnosis of unipolar or bipolar depression (seasonal or non-seasonal) as assessed with the Mini-International Neuropsychiatric Interview (M.I.N.I.)
- A current depressive episode (a score of 6 or higher on the Quick Inventory of depressive symptomatology Self Report (QIDS-SR)
- Sufficient knowledge of Dutch or English language to fill in questionnaires
- Provided Informed consent
- A current (hypo)manic or mixed episode (as assessed with the M.I.N.I.)
- Current psychotic episode (as assessed with the M.I.N.I.)
- Prominent active suicidality (score 10 or higher on the M.I.N.I. module)
- Antidepressant therapy (medication, psychotherapy or BLT, or other forms of specific treatments for depression) that started less than 2 months prior to study entry
- participants with bipolar disorder should be in mood-stabilizing treatment for at least 1 month in a recommended dosage,
- Use of melatonin or agomelatine in the last month
- Current use of antibiotics
- Current use of light sensitivity increasing medication
- Travelled across more than 1 time zone during past month or during the treatment
- Travelled to sunny holiday locations/winter sports during past month
- pre-existing eye and skin disorders (retinitis pigmentosa, porphyria, chronic actinic dermatitis and sun-induced urticaria)
- Systemic disorders with potential retinal involvement (rheumatoid arthritis and systemic lupus erythematosus)
- Suffering from colour blindness (assessed by Ishihara colour plates)
- Participated in night shift work in the last three months
- (Retinal) blindness, severe cataract and glaucoma
- Light-induced migraine or epilepsy
- Pregnancy, or parents with a child younger than 18 months old
The study team makes the final eligibility decision.
Where it's taking place
- Eindhoven, Netherlands
- Leiden, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Eindhoven, Netherlands; Leiden, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.