Clinical trial NCT02664467: Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project
Official title: Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depression, Postpartum
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Pregnancy Complications
Puerperal Disorders
Lead sponsor: Ospedale Regionale di Lugano
Sponsor class: OTHER
Collaborators: name: University of Bologna
name: University of Milan
name: University of Turin, Italy
First posted: 2016-01-27
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Medically healthy
* Normal ocular function
* Gestational age between 10 to 15 weeks at time of screening
* Written informed consent

Exclusion Criteria:

* Diagnosis of bipolar I or II disorder (DSM-5)
* Recent history (less than 6 months) or current major depression or an Edinburgh Postnatal Depression Scale (EPDS) score \> 12 at time of inclusion
* Any psychotic episode, substance abuse, recent history of suicide attempt (less than 12 months)
* Use of antidepressants or other pharmacologic treatments for depression in the last 6 months
* Fetal malformations and intrauterine fetal death

Primary outcomes:
measure: Change in Depression Score as assessed by the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: during 6 weeks of light treatment plus 12 months observation
measure: Change in Depression Score as assessed by the Hamilton Depression Rating scale - 21 items (HDRS-21)
timeFrame: during 6 weeks of light treatment plus 12 months observation
measure: Change in Depression Score as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: during 6 weeks of light treatment plus 12 months observation
Secondary outcomes:
measure: Objective sleep-related markers and risk factors for perinatal depression as assessed by home polysomnography
timeFrame: at 23th-25th week of gestation
measure: Objective sleep-related markers and risk factors for perinatal depression as assessed by wrist actigraphy
timeFrame: observation over a period of 2 years
measure: Analysis of genetic risk factors for perinatal depression by single blood test
timeFrame: at 23th-25th week of gestation
measure: Subjective mood changes as assessed by the Visual Analog Scale for Depression (VAS)
timeFrame: during 6 weeks of light treatment plus 12 months observation
measure: Number of participants with treatment-related adverse events as assessed by the Systematic Assessment for Treatment Emergent Events (SAFTEE)
timeFrame: during 6 weeks of light treatment plus 12 months observation
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Neurocenter of Southern Switzerland
state: Ticino
Study officials:
References:
citation: Baiardi S, Cirignotta F, Cicolin A, Garbazza C, D'Agostino A, Gambini O, Giordano A, Canevini M, Zambrelli E, Marconi AM, Mondini S, Borgwardt S, Cajochen C, Rizzo N, Manconi M. Chronobiology, sleep-related risk factors and light therapy in perinatal depression: the "Life-ON" project. BMC Psychiatry. 2016 Nov 4;16(1):374. doi: 10.1186/s12888-016-1086-0.