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Optimization, Working Mechanisms and Response Predictors of Bright Light Therapy for Depressive Disorders- a multicenter randomized controlled trial

Optimization, Working Mechanisms and Response Predictors of Bright Light Therapy for Depressive Disorders- a multicenter randomized controlled trial - BioClock: Bright light therapy for depressive disorders

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53312
Enrollment
231
Registered
2023-10-17
Start date
2024-02-08
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression Depressive Disorders

Interventions

In all arms, patients will receive 10,000 lux BLT in the morning for 30 min/day on 5 consecutive days. Treatment duration will be one, two or three weeks, depending on the remittance of depressive s

Sponsors

Universiteit Leiden
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age between 18 and 65. - Diagnosis of unipolar or bipolar depression (seasonal or non-seasonal) - A current depressive episode - Sufficient knowledge of Dutch or English language to fill in questionnaires

Exclusion criteria

Exclusion criteria: - A current (hypo)manic or mixed episode - Current psychotic episode - Prominent active suicidality - Antidepressant therapy that started less than 2 months prior to study entry - Participants with bipolar disorder that are not on mood stabilizing medication in a recommended dose for the last month prior to study entry - Use of melatonin or agomelatine in the last month - Current use of antibiotics - Current use of light sensitivity-increasing medication - Travelled more than 1 time zone or to a sunny holiday destination/wintersports during the 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 (retinal) blindness, severe cataract, glaucoma or colour blindness - Participated in night shift work in the last three months - Light-induced migraine and epilepsy - Pregnancy

Design outcomes

Primary

MeasureTime frame
The primary outcome is clinical improvement, as indexed by a difference in MADRS scores between the baseline and 4 weeks after the start of treatment.

Secondary

MeasureTime frame
Secondary clinical outcome measures are: time to recovery (the number of treatment weeks needed to achieve remission), remission rate (percentage of patients that score lower than 6 on the MADRS 4 weeks after the start of the treatment); and response rate (percentage of patients with at least 50% reduction in MADRS -score).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)