Understanding fatigue in people with schizophrenia
Correlates of Fatigue in People with Schizophrenia
This study is testing how different factors affect fatigue in adults with schizophrenia who are in rehabilitation, by tracking their activity and sleep for a week.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 61 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gcs Cips Academic / other |
| Locations | 1 site (La Crau) |
| Trial ID | NCT06397950 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a model explaining the factors contributing to fatigue in adults with schizophrenia who are undergoing psychosocial rehabilitation. Participants will wear accelerometers for a week to monitor their physical activity and sleep patterns. Following this, they will undergo assessments to evaluate fatigue levels, cognitive function, and other related health metrics. The study seeks to identify clinical characteristics that differentiate highly fatigued individuals from those with lower fatigue levels.
Who should consider this trial
Good fit: Ideal candidates are adults with schizophrenia who are actively engaged in a psychosocial rehabilitation process and have stable medication regimens.
Not a fit: Patients experiencing significant physical pain or those with severe substance addictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for fatigue in patients with schizophrenia, enhancing their quality of life.
How similar studies have performed: While fatigue is a recognized issue in schizophrenia, this specific approach to understanding its correlates is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with schizophrenia engaged in a psychosocial rehabilitation process. * Patient with a stabilised evolution according to usual literature criteria (no modification or increase in antipsychotic treatment during the 4 weeks prior to inclusion). * Absence of characterised major depressive episode. * Patient affiliated or entitled to a social security scheme. * Obtention of free and informed written consent, as well as the free and informed written consent of the guardian in the case of a patient placed under protection measure (guardianship). Exclusion Criteria: * Physical pain superior to 3 on a visual analog scale. * History of severe inflammatory pathology or severe brain trauma. * Medical contraindication to moderate-intensity physical activity practice. * Patient having electroconvulsive therapy as current treatment. * Addiction to toxic products such as alcohol, cannabis or other toxic substances other than tobacco.
Where this trial is running
La Crau
- Clinique INICEA Val Du Fenouillet — La Crau, France (Recruiting)
Study contacts
- Principal investigator: Emmanuel MULIN — Inicea
- Study coordinator: Nelly HERAUD, PhD
- Email: nelly.heraud@clariane.fr
- Phone: 0468686960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.