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Indoor Artificial Light at Night and the Relapse Risk of Schizophrenia

Sponsor
Weizhuo Yi (Other)
Overall Status
Completed
CT.gov ID
NCT05986409
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
2
Actual Duration (Months)
25.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: light cover
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
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
Actual Study Start Date :
Aug 1, 2022
Actual Primary Completion Date :
Sep 15, 2022
Actual Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: opaque black tape covering part of the light source

10 wards were randomly selected as the intervention group (opaque black tape covering part of the light source).

Other: light cover
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).
No Intervention: no intervention

another 10 wards were selected as the control group (no intervention)

Outcome Measures

Primary Outcome Measures

  1. Relapse risk [up to 24 weeks]

    Relapse risk was assessed by Chinese version of the Early Signs Scale (ESS). The ESS scale consists of 34 items (e.g., recently been bothered by 1 or 2 small things in life; To feel down and down; Other people don't understand me; Difficulty concentrating; It feels as if the thoughts are not my own... Etc.). Each entry is rated from 0 points (0 times/week), 1 score (1 time/week), 2 scores (more than 1 time/week) to 3 scores (at least 1 time/day), and all entries total 102 scores. The ESS scale has 4 dimensions, which are: Anxiety/agitation (ESS-A, 7 items); Depression/withdrawal (ESS - N, 10 items); Excitability/disinhibition (ESS-D, 6 items); Incipient psychosis (ESS-IP, 11 items).

Secondary Outcome Measures

  1. Cognitive function [up to 24 weeks]

    The Montreal Cognitive Assessment (MoCA) is a widely used cognitive screening test designed to assess various cognitive functions, including memory, attention, language, and visuospatial abilities. It was created by Dr. Ziad Nasreddine in Montreal, Canada, in 1996, and it has since become a valuable tool for detecting mild cognitive impairment (MCI) and early signs of dementia, especially Alzheimer's disease. The MoCA consists of a series of tasks and questions that evaluate different cognitive domains. The total score on the MoCA is 30 points, with a higher score indicating better cognitive function. A score of 26 or above is considered normal for most individuals, although the normal range can vary based on factors such as age and education level.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Clinical diagnosis of schizophrenia

  • Regularly taking antipsychotics

Exclusion Criteria:

  • Infectious diseases

  • Gastrointestinal diseases

  • Using antibiotics

Contacts and Locations

Locations

Site City State Country Postal Code
1 Weizhuo Yi Hefei Anhui China 230031

Sponsors and Collaborators

  • Weizhuo Yi

Investigators

  • Principal Investigator: Rubing Pan, Dr., Anhui Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weizhuo Yi, Director, Anhui Medical University
ClinicalTrials.gov Identifier:
NCT05986409
Other Study ID Numbers:
  • 20140101
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Recurrence
Schizophrenia

Study Results

No Results Posted as of Aug 14, 2023