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

Recruiting

Conditions: Depression
Depressive Disorders
10027946

Registration Number: NL-OMON53312

Lead Sponsor: niversiteit Leiden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 231

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is clinical improvement, as indexed by a difference in<br /><br>MADRS scores between the baseline and 4 weeks after the start of treatment. </p><br>

Secondary Outcome Measures

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