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

Phase 4

• Conditions: F32.1; F32.2; F33.1; F33.2; F92.0; Moderate depressive episode; Severe depressive episode without psychotic symptoms; Recurrent depressive disorder, current episode moderate; Recurrent depressive disorder, current episode severe without psychotic symptoms; Depressive conduct disorder

• Registration Number: DRKS00013188
• Lead Sponsor: Dekan der Medizinischen Fakultät der Ruhr-Universität Bochum

Brief Summary

Results: Among the 224 patients included in the intention-to-treat analyses (192 girls and 32 boys; mean [SD] age, 15.5 [1.4] years), the mean (SD) BDI-II score at baseline was 37.3 (8.7). BDI-II scores were significantly reduced after 4 weeks (postassessment) by a mean of -7.5 (95% CI, -9.0 to -6.0; Hedges g = 0.71). Bright light therapy had no impact on this change (no significant group × time effect). Loss to follow-up was 31% (n = 69) at 16 weeks and 49% (n = 110) at 28 weeks. There were 10 serious adverse events throughout the whole trial, which were not considered related to study treatment. Conclusions and relevance: The findings in this study did not indicate superiority of bright light therapy over placebo red light therapy in a large sample of adolescent inpatients with moderate or severe major depressive disorder. Both groups benefited equally from treatment as usual, showing relevant symptom reduction.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-30
• Study Completion: 2021-06-03
• Results First Posted: 2024-03-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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