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