Combined wake and light therapy in children and adolescents with depression and affective dysregulation

Combined wake and light therapy in children and adolescents with depression and affective dysregulation: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN64183687

Enrollment

Registered

2013-09-30

Start date

2012-12-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Juvenile depression and affective dysregulation Mental and Behavioural Disorders

Interventions

Patients will be randomly assigned to the following two groups (2:2). 1. Control group: 45 min morning light therapy (10.000 Lux, DAVITA LD 110) approx. 8.5 h after estimated melatonin-onset [DLMO, a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Moderate to severe depression assessed by the Beck Depression Inventory (BDI-II) 2. Boys and girls aged 13-18 years 3. Ability of a patient to understand character and individual consequences of such a clinical trial 4. Written informed consent of the person with primary custody must be available before enrolment in the trial

Exclusion criteria

Exclusion criteria: 1. Acute suicidality 2. Pregnancy or lactation 3. Treatment with beta-blocker 4. Bipolar 1 Disorder, schizophrenia 5. Diseases of the eye with involvement of the retina 6. Highly potent neuroleptics 7. Narcolepsy

Design outcomes

Primary

Measure	Time frame
Change in depression rating scale at pre-test, post tests: directly after intervention (post-test 1), two weeks after intervention (post-test 2), four weeks after intervention (post-test 3) and 6 months after intervention (follow up) (assessed by BDI-II)	—

Secondary

Measure	Time frame
The following will be assessed at pre-test, all post-tests and at the follow up: 1. Clinical Global Impressions - Severity (CGI-S) Scale (at pre-test) and Clinical Global Impressions - Improvement (CGI-I) Scale (at all post-test) 2. Sleep parameters (Schlaffragebogen B; Görtelmeyer, 2011) 3. Number of responders (Clinical Global Impression- Improvement (CGI-I) from 1 to 2 / 25% improvement on BDI-II) 4. Strengths and Difficulties Questionnaire ? parent- and self-rating (SDQ; Goodman et al., 1997) (not at post-test 3) 5. Parameters of attention: alertness, flexibility, divided attention, go/nogo (not at post-test 3) 6. Dim Light Melantonin Onset (DLMO) (not at follow up) 7. Assessment of adverse events The following parameters are only accessed once: 1. Therapy expectancy (pre-test) 2. Assessment of the individual chronotype (Horne-Ostberg-Morningness-Eveningness-Questionnaire, MEQ ? german version; D-MEQ; Griefahn et al., 2001) (pre-test) 3. Child Behaviour Checklist (CBCL) / 4-18 (pre-test) 4. Activation level at day and night while intervention determined by actimeters	—

Measure

Time frame

The following will be assessed at pre-test, all post-tests and at the follow up: 1. Clinical Global Impressions - Severity (CGI-S) Scale (at pre-test) and Clinical Global Impressions - Improvement (CGI-I) Scale (at all post-test) 2. Sleep parameters (Schlaffragebogen B; Görtelmeyer, 2011) 3. Number of responders (Clinical Global Impression- Improvement (CGI-I) from 1 to 2 / 25% improvement on BDI-II) 4. Strengths and Difficulties Questionnaire ? parent- and self-rating (SDQ; Goodman et al., 1997) (not at post-test 3) 5. Parameters of attention: alertness, flexibility, divided attention, go/nogo (not at post-test 3) 6. Dim Light Melantonin Onset (DLMO) (not at follow up) 7. Assessment of adverse events The following parameters are only accessed once: 1. Therapy expectancy (pre-test) 2. Assessment of the individual chronotype (Horne-Ostberg-Morningness-Eveningness-Questionnaire, MEQ ? german version; D-MEQ; Griefahn et al., 2001) (pre-test) 3. Child Behaviour Checklist (CBCL) / 4-18 (pre-test) 4. Activation level at day and night while intervention determined by actimeters

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026