跳至主要内容
临床试验/DRKS00013188
DRKS00013188已完成4 期

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

Dekan der Medizinischen Fakultät der Ruhr-Universität Bochum0 个研究点目标入组 227 人开始时间: 2017年11月30日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
227

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
12 Years 至 18 Years(—)
性别
All

入选标准

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

排除标准

  • 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

研究者

发起方
Dekan der Medizinischen Fakultät der Ruhr-Universität Bochum

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