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

NCT02664467 | Completed

• 1 other identifier: ORLugano
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Depression, Postpartum; Depressive Disorder; Depressive Disorder, Major; Mood Disorders; Pregnancy Complications; Puerperal Disorders

Outcome Measures

Primary Outcomes (3)

• Change in Depression Score as assessed by the Edinburgh Postnatal Depression Scale (EPDS)

  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)

  during 6 weeks of light treatment plus 12 months observation

• Change in Depression Score as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

  during 6 weeks of light treatment plus 12 months observation

Secondary Outcomes (5)

• Objective sleep-related markers and risk factors for perinatal depression as assessed by home polysomnography

  at 23th-25th week of gestation

• Objective sleep-related markers and risk factors for perinatal depression as assessed by wrist actigraphy

  observation over a period of 2 years

• Analysis of genetic risk factors for perinatal depression by single blood test

  at 23th-25th week of gestation

• Subjective mood changes as assessed by the Visual Analog Scale for Depression (VAS)

  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)

  during 6 weeks of light treatment plus 12 months observation

Study Arms (2)

Bright light therapy (BLT)

EXPERIMENTAL

Bright light therapy (10'000 lux) for 30 minutes after wake-up using Philips EnergyUp EnergyLight HF3419/01

Device: Philips EnergyUp EnergyLight HF3419/01

Placebo dim light

PLACEBO COMPARATOR

Placebo dim light (50 lux) for 30 minutes after wake-up using Philips EnergyUp EnergyLight HF3419/01

Device: Philips EnergyUp EnergyLight HF3419/01

Interventions

Philips EnergyUp EnergyLight HF3419/01 DEVICE

Bright light therapy (10'000 lux) for 60 minutes after wake-up

Bright light therapy (BLT)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Diagnosis of bipolar I or II disorder (DSM-5)
• 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

Sponsors & Collaborators

• Ospedale Regionale di Lugano: lead
• University of Bologna: collaborator
• University of Milan: collaborator
• University of Turin, Italy: collaborator

Study Sites (1)

Neurocenter of Southern Switzerland

Lugano, Canton Ticino, 6900, Switzerland

Location

Related Publications (2)

• Garbazza C, Cirignotta F, D'Agostino A, Cicolin A, Hackethal S, Wirz-Justice A, Cajochen C, Manconi M; "Life-ON" study group. Sustained remission from perinatal depression after bright light therapy: A pilot randomised, placebo-controlled trial. Acta Psychiatr Scand. 2022 Oct;146(4):350-356. doi: 10.1111/acps.13482. Epub 2022 Aug 3.

  PMID: 35876837 DERIVED

• 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.

  PMID: 27814712 DERIVED

MeSH Terms

Conditions

Depression; Depression, Postpartum; Depressive Disorder; Depressive Disorder, Major; Mood Disorders; Pregnancy Complications; Puerperal Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Mauro Manconi

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 27, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2020
• Last Updated: March 4, 2021

Record last verified: 2021-03

Locations

CH (1)