Indoor Artificial Light at Night and the Relapse Risk of Schizophrenia

NCT05986409 | Completed

• 1 other identifier: 20140101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia Relapse; Light Pollution

Outcome Measures

Primary Outcomes (1)

• Relapse risk

  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).

  up to 24 weeks

Secondary Outcomes (1)

• Cognitive function

  up to 24 weeks

Study Arms (2)

opaque black tape covering part of the light source

EXPERIMENTAL

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

Other: light cover

no intervention

NO INTERVENTION

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

Interventions

light cover OTHER

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).

opaque black tape covering part of the light source

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of schizophrenia
• Regularly taking antipsychotics

You may not qualify if:

• Infectious diseases
• Gastrointestinal diseases
• Using antibiotics

Sponsors & Collaborators

• Weizhuo Yi: lead

Study Sites (1)

Weizhuo Yi

Hefei, Anhui, 230031, China

Location

Study Officials

• Rubing Pan, Dr.

  Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 30, 2022
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)