Clinical Trial: Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project

Brief Summary:

In a 3 years longitudinal, observational, multicentre study, about 500 women will be recruited and followed-up from early pregnancy (10-15 gestational week) until 12 months after delivery. The primary aim of the present study is to systematically explore and characterize risk factors for perinatal depression (PND) by prospective sleep assessment (using wrist actigraphy, polysomnography and various sleep questionnaires) and blood based analysis of potential markers during the perinatal period (Life-ON study). Secondary aims are to explore the relationship between specific genetic polymorphisms and PND (substudy Life-ON1), to investigate the effectiveness of BLT in treating PND (substudy Life-ON2) and to test whether a short term trial of BLT during pregnancy can prevent PND (substudy Life-ON3).

The characterization of specific predictive and risk factors for PND may substantially contribute to improve preventive medical and social strategies for the affected women. The study results are expected to promote a better understanding of the relationship between sleep disorders and the development of PND and to confirm, in a large sample of women, the safety and efficacy of BLT both in prevention and treatment of PND.


Detailed Summary:
Sponsor: Ospedale Regionale di Lugano

Current Primary Outcome:

  • Change in Depression Score as assessed by the Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: during 6 weeks of light treatment plus 12 months observation ]
  • Change in Depression Score as assessed by the Hamilton Depression Rating scale - 21 items (HDRS-21) [ Time Frame: during 6 weeks of light treatment plus 12 months observation ]
  • Change in Depression Score as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: during 6 weeks of light treatment plus 12 months observation ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Objective sleep-related markers and risk factors for perinatal depression as assessed by home polysomnography [ Time Frame: at 23th-25th week of gestation ]
  • Objective sleep-related markers and risk factors for perinatal depression as assessed by wrist actigraphy [ Time Frame: observation over a period of 2 years ]
  • Analysis of genetic risk factors for perinatal depression by single blood test [ Time Frame: at 23th-25th week of gestation ]
  • Subjective mood changes as assessed by the Visual Analog Scale for Depression (VAS) [ Time Frame: during 6 weeks of light treatment plus 12 months observation ]
  • Number of participants with treatment-related adverse events as assessed by the Systematic Assessment for Treatment Emergent Events (SAFTEE) [ Time Frame: during 6 weeks of light treatment plus 12 months observation ]


Original Secondary Outcome: Same as current

Information By: Ospedale Regionale di Lugano

Dates:
Date Received: January 13, 2016
Date Started: May 2016
Date Completion: November 2019
Last Updated: September 19, 2016
Last Verified: September 2016