Chronotherapy in children and adolescents with depression and affective dysregulation

Chronotherapy in children and adolescents with depression and affective dysregulation: a double-blind randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN89305231

Enrollment

Registered

2011-08-11

Start date

2011-08-01

Completion date

Unknown

Last updated

2015-01-13

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 Other behavioural and emotional disorders with onset usually occurring in childhood and adolescence

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Moderate to severe depression [assessed by the Beck Depression Inventory (BDI) II] 2. 12-18 years of age 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 antidepressants 4. Treatment with beta-blocker 5. Bipolar 1 Disorder, schizophrenia 6. Diseases of the eye with involvement of the retina 7. Highly potent neuroleptics

Design outcomes

Primary

Measure	Time frame
Change in depression rating scale at pre-test, post-test 1, post-test 2, post-test 3, post-test 4 and follow up (assessed by BDI II)	—

Secondary

Measure	Time frame
The following will be assessed at pre-test, post-test 1, and follow-up: 1. Clinical Global Impressions - Severity (CGI-S) Scale (at pre-test) and Clinical Global Impressions - Improvement (CGI-I) Scale (at post-test 1 and follow-up) 2. Sleep parameters (Schlaffragebogen B; Görtelmeyer, 2011) 3. Number of responder [ 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) 5. Parameters of attention: alertness, flexibility, Go-No / Go, divided attention (Zimmermann & Fimm, 2009) 6. Dim Light Melantonin Onset (DLMO) and cortisol ? saliva-melatonin and saliva-cortisol 7. Therapy expectancy 8. Assessment of the individual chronotype (Horne-Ostberg-Morningness-Eveningness-Questionnaire, MEQ ? german version; D-MEQ; Griefahn et al., 2001) 9. Child Behaviour Checklist (CBCL) / 4-18 10. Assessment of adverse events	—

Measure

Time frame

The following will be assessed at pre-test, post-test 1, and follow-up: 1. Clinical Global Impressions - Severity (CGI-S) Scale (at pre-test) and Clinical Global Impressions - Improvement (CGI-I) Scale (at post-test 1 and follow-up) 2. Sleep parameters (Schlaffragebogen B; Görtelmeyer, 2011) 3. Number of responder [ 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) 5. Parameters of attention: alertness, flexibility, Go-No / Go, divided attention (Zimmermann & Fimm, 2009) 6. Dim Light Melantonin Onset (DLMO) and cortisol ? saliva-melatonin and saliva-cortisol 7. Therapy expectancy 8. Assessment of the individual chronotype (Horne-Ostberg-Morningness-Eveningness-Questionnaire, MEQ ? german version; D-MEQ; Griefahn et al., 2001) 9. Child Behaviour Checklist (CBCL) / 4-18 10. Assessment of adverse events

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026