Trial document




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  DRKS00013188

Trial Description

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Title

Depression in adolescents: A double-blind randomised controlled trial of Bright
Light Therapy in a naturalistic inpatient setting.

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Trial Acronym

DeLight

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URL of the Trial

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Brief Summary in Lay Language

Depressive disorders are among the most prominent health problems in youth. Even with the best available pharmacological and non-pharmacological treatments, treatment responses are low. Without early treatment, depression in youth is associated with a high risk of symptom progression, chronicity, comorbidity and suicidal behaviour. Thus, adolescent depression is a prime candidate for innovation in treatment. In depressive adults, meta-analytic evidence has proven that bright light therapy (BLT) is promising due to easy application, low side effects and optimized compliance. In adolescents, studies in small samples show promising effects. This study want to assess whether four weeks of BLT (daily morning exposure to bright light via light emitting glasses,10.000 lux, for 30 minutes) in inpatient youth with moderate to severe depression reduces symptoms with greater effect compared to a control condition (placebo red light, identical light glasses, without effects on depression). BLT will be provided in addition to guideline-based multimodal treatment as usual (TAU) for inpatients with juvenile depression. N=224 patients will be recruited in a naturalistic inpatient setting.

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Brief Summary in Scientific Language

Depressive disorders are among the most prominent health problems in youth. Even with the best available pharmacological and non-pharmacological treatments, remission rates are low. Without early treatment, depression in youth is associated with a high risk of symptom progression, chronicity, comorbidity and suicidal behaviour. Thus, juvenile depression is a prime candidate for innovation in treatment. In depressive adults, meta-analytic evidence has proven that bright light therapy (BLT) is a potent low-threshold intervention, promising due to easy application, low side effects and optimized compliance. In adolescents, studies in small samples show promising effects. The primary objective of the underlying randomized, double-blind, controlled trial is to assess whether four weeks of BLT (daily morning exposure to bright light via light emitting glasses,10.000 lux, for 30 minutes) in inpatient youth with moderate to severe depression reduces symptoms with greater effect compared to a control condition (placebo light treatment, red light, identical light glasses, without effects on depression). BLT will be provided in addition to guideline-based multimodal treatment as usual (TAU) for inpatients with juvenile depression. N=224 patients will be recruited in a naturalistic inpatient setting.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013188
  •   2017/11/30
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  •   yes
  •   Approved
  •   17-6140, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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Health Condition or Problem studied

  •   F32.1 -  Moderate depressive episode
  •   F32.2 -  Severe depressive episode without psychotic symptoms
  •   F33.1 -  [---]*
  •   F33.2 -  Recurrent depressive disorder, current episode severe without psychotic symptoms
  •   F92.0 -  Depressive conduct disorder
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Interventions/Observational Groups

  •   Morning bright light therapy, light glasses, 10.000 Lux, 4 weeks, 30 minutes/day
  •   Morning placebo light therapy, light glasses, red light, 4 weeks, 30 minutes/day
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Self-reported depressive symptoms after two and four weeks of treamtent-onset (BDI-II)

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Secondary Outcome

- changes in depressive symptoms after three (T3) and six (T4) months with BDI-II
- Clinical Global Impression of improvements with CGI-Improvement after the Intervention (T2) and after three (T3) and six (T4) months
- improvement and number of treatment responders defined as CGI-I≤2 and BDI≤28 after the Intervention (T2)
- Clinical Impression of changes in depressive symptoms; Children`s Depression Rating Scale-Revised (CDRS-R; Keller et al., 2011; Plener et al., 2012): before (T1) and after (T2) the Intervention and after three (T3) and six (T4) months
- Antidepressant Medication Status: Changes
in the treatment regime (initiation/cessation/dose-adjustment of antidepressants) will be assessed weekly
from baseline until the end of the treatment
- Sleep behavior and - Quality (measured with "Schlaffragebogen"; SF-BR; Görtelmeyer et al., 2001), Changes in well-being (KIDSCREEN-10), Physical activity (Domain Resilience of CHIP-AE), General psychopathology (Strengths and Difficulties Questionnaire; SDQ): before (T1) and after (T2) the intervention and after three (T3) and six (T4) months
- Changes in sleep and activity will be objectively measured with actigraphy before (T1) and after (T2) the intervention
- Changes in level of
alertness will be assessed via the subtest “Alertness” of the Testbattery for Attentional Performance
(TAP, Zimmermann & Fimm 2002): before (T1) after after (T2) the intervention
- Changes in Melatonin and Cortisol will be measured with saliva samples: 5 samples per Patient (T1, T2)
- Adverse Events will be measured directly after the intervention (T2) and three (T3) and six (T4) months after the Intervention (Follow-up)

Expected and measured moderating variables: -The chronotype (Horne-Ostberg-Morningness-Eveningness-Questionnaire – MEQ – deutsche Version, D-MEQ): before (T1) and after (T2) the intervention and after three (T3) and six (T4) months
- the Impact of seasonal Patterns (Seasonal Pattern Assessment Questionaire – SPAQ): before Intervention (T1)
- intelligence ("Zahlen-Verbindungstest"; ZVT): before Intervention (T1)
- treatment expectations (before intervention(T1)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/03/26
  •   224
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   12   Years
  •   18   Years
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Additional Inclusion Criteria

Moderate to severe depression (ICD-10 / Beck Depression
Inventory II, BDI-II), inpatients, 12-18 years of age, written informed
consent/assent.

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Exclusion Criteria

suicidality, pregnancy or lactation, treatment with betablocker
or neuroleptics, bipolar 1 disorder, schizophrenia, diseases of the Retina, IQ<70, insufficient knowledge of German language of the patient or his/her parents

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Addresses

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    • Dekan der Medizinischen Fakultät der Ruhr-Universität Bochum
    • Universitätsstraße 150
    • 44801  Bochum
    • Germany
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    •   [---]*
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    • LWL-Universitätsklinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik
    • Mr.  Prof. Dr. Dr.  Martin  Holtmann 
    • Heithofer Allee 64
    • 59071  Hamm
    • Germany
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    • LWL-Universitätsklinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik
    • Ms.  Maren  Terwege 
    • Heithofer Allee 64
    • 59071  Hamm
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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  •   2021/06/03
  •   134
  •   134
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Trial Publications, Results and other Documents

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