Clinical Trials Directory

Trials / Completed

CompletedNCT05986409

Indoor Artificial Light at Night and the Relapse Risk of Schizophrenia

The Role of Microbiota-gut-brain Axis as a Mediator in the Association Between Indoor Artificial Light at Night and the Relapse Risk of Schizophrenia: a Randomized, Crossover Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Weizhuo Yi · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

A randomized crossover trial of ALAN intervention was conducted in patients with chronic schizophrenia in Anhui Mental Health Center from August 15 to September 30, 2022. All participants met the diagnostic criteria for schizophrenia in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V). The enrolled patients were in the symptom-stable phase and were regularly prescribed antipsychotics (no change in medication regimen). The diets of all the participants were uniformly supplied during study. Patients with infectious diseases, eye diseases, or gastrointestinal diseases, or who used antibiotics at the time of recruitment, were excluded. The wards of the participants were all located in the same inpatient building. All included wards had the same size, layout, lighting and orientation of doors and windows. In normal conditions, each ward retains a small LED lamp (the same layout in all wards) at night as a source of lighting. The study was divided into two stages. In the first stage, 10 wards were randomly selected as the intervention group (opaque black tape covering part of the light source), and another 10 wards were selected as the control group (no intervention). After a two-week washout interval, the second stage was carried out, with the two groups interchanging interventions. At the end of each intervention, participants completed a structured questionnaire scale to assess the relapse risk of schizophrenia, and then their fecal samples were collected.

Conditions

Interventions

TypeNameDescription
OTHERlight cover10 wards were randomly selected as the intervention group (opaque black tape covering part of the light source), and another 10 wards were selected as the control group (no intervention).

Timeline

Start date
2022-08-01
Primary completion
2022-09-15
Completion
2022-09-30
First posted
2023-08-14
Last updated
2023-08-14

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05986409. Inclusion in this directory is not an endorsement.