Triple chronotherapy (combined total sleep deprivation, sleep phase advance and bright light therapy) to reduce acute depressive and suicidal symptoms: a randomized controlled clinical trial

Study type

• Study type:
  Clinical trial
• Scope of the study:
  Effectiveness study (incl. comparative)

Study drug and medical condition

• Medical condition to be studied:
  Depression suicidal

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Estimated number of subjects:
  75

Study design details

• Main study objective:
  To assess the efficacy of a Triple Chronotherapy add-on intervention in patients hospitalized for a Depressive Episode. Triple Chronotherapy includes Sleep Deprivation (SD) - Sleep Phase Advance (SPA) and Bright Light Therapy (BLT).
• Outcomes:
  50% change from baseline associated with Triple Chronotherapy add-onintervention in the Hamilton Depression Rating Scale (HAMD-17) score, 50% score reduction of HAMD-17, reduction of suicidality at the Nurses' Global Assessment of Suicide Risk (NGASR) and Columbia Suicide Severity Rating Scale (C-SSRS), improved sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), Length of Stay (LoS)
• Data analysis plan:
  Continuous variables will be described as means and standard deviation after Kolmogorov-Smirnov normality check. Non-normal variables will be described as medians and quartiles. Multiple imputation will be employed for missing data.Multivariate models will be used for between-groups comparisons. Binary logistic regression will be used with a dichotomous score based on the primary outcome to discern responders from non-responders. Goodness-of-fit and effect size will be evaluated and confidence intervals set at 95%