Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-29 @ 2:22 PM
Study NCT ID:
NCT06397950
Status:
TERMINATED
Last Update Posted:
2025-07-31
First Post:
2024-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlates of Fatigue in People With Schizophrenia
Sponsor:
GCS CIPS
Organization:
Study Overview
Official Title:
Correlates of Fatigue in People With Schizophrenia
Status:
TERMINATED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment difficulties caused by a lack of eligible patients in the investigating center, calling into question the feasibility of the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIZO-2
Brief Summary:
The goal of this experimental prospective study is to build an explicative model of trait fatigue in adults with schizophrenia engaged in a psychosocial rehabilitation process.
The main questions it aims to answer are:
* Which factors amongst those evaluated explain the most of fatigue variance in people with schizophrenia?
* Which clinical factors characterise the most fatigued participants compared to less fatigued participants?
Participants will wear an accelerometer for seven days to assess their sedentary and physical activity behaviours as well as their sleep.
After this, they will undergo an experimental visit, to asses:
* Fatigue
* Cognitive function
* Tobacco and caffeine consumption
* Fatigue catastrophizing
* Sleep quality
* Sarcopenia risk
* Functional capacities
* Handgrip strength
* Quadriceps maximal strength and fatigability
The main questions it aims to answer are:
* Which factors amongst those evaluated explain the most of fatigue variance in people with schizophrenia?
* Which clinical factors characterise the most fatigued participants compared to less fatigued participants?
Participants will wear an accelerometer for seven days to assess their sedentary and physical activity behaviours as well as their sleep.
After this, they will undergo an experimental visit, to asses:
* Fatigue
* Cognitive function
* Tobacco and caffeine consumption
* Fatigue catastrophizing
* Sleep quality
* Sarcopenia risk
* Functional capacities
* Handgrip strength
* Quadriceps maximal strength and fatigability
Detailed Description:
Schizophrenia is a severe mental illness affecting about 1% of worldwide population. Diagnostic relies on multiple symptoms, divided into three main categories: positive symptoms, negative symptoms and cognitive/dissociative symptoms. Antipsychotic medication is actually the main pharmacologic treatment in schizophrenia but adverse effects can exacerbate other symptoms such as fatigue.
Fatigue has a high prevalence in schizophrenia. Unfortunately, fatigue has negative repercussions on daily living activities in this population, and no effective treatment has been identified for now. The lack of effective strategies to manage fatigue in schizophrenia can be due to the lack of knowledge about factors that can explain fatigue. As such, an explicative model of fatigue in schizophrenia has yet to be established.
Because fatigue is a complex and multifactorial mechanism, investigating its correlates could allow to propose new avenues for its multidisciplinary management, in order to delay its onset or minimize its negative impact. In comparison to healthy subjects, people with schizophrenia show increased physical inactivity and sedentary levels, worsened physical fitness and higher risks of sarcopenia, disturbed sleep, altered cognitive function, increased consumption of psychoactive substances (coffee and tobacco), an increased fatigue catastrophizing. Moreover, negative symptoms could also be linked to fatigue as it has been shown that fatigue could contribute to anhedonia in schizophrenia. Finally, antipsychotic medication can induce sedation, overlapping with fatigue, contributing to an exacerbated experience of the symptom.
Therefore, the goal of this study is to investigate whether physical inactivity, sedentary behaviour, physical fitness, sarcopenia risk, sleep, cognitive capacities, psychoactive substance consumption, fatigue catastrophizing, antipsychotic treatment and negative symptoms could contribute to fatigue in people in schizophrenia.
Fatigue has a high prevalence in schizophrenia. Unfortunately, fatigue has negative repercussions on daily living activities in this population, and no effective treatment has been identified for now. The lack of effective strategies to manage fatigue in schizophrenia can be due to the lack of knowledge about factors that can explain fatigue. As such, an explicative model of fatigue in schizophrenia has yet to be established.
Because fatigue is a complex and multifactorial mechanism, investigating its correlates could allow to propose new avenues for its multidisciplinary management, in order to delay its onset or minimize its negative impact. In comparison to healthy subjects, people with schizophrenia show increased physical inactivity and sedentary levels, worsened physical fitness and higher risks of sarcopenia, disturbed sleep, altered cognitive function, increased consumption of psychoactive substances (coffee and tobacco), an increased fatigue catastrophizing. Moreover, negative symptoms could also be linked to fatigue as it has been shown that fatigue could contribute to anhedonia in schizophrenia. Finally, antipsychotic medication can induce sedation, overlapping with fatigue, contributing to an exacerbated experience of the symptom.
Therefore, the goal of this study is to investigate whether physical inactivity, sedentary behaviour, physical fitness, sarcopenia risk, sleep, cognitive capacities, psychoactive substance consumption, fatigue catastrophizing, antipsychotic treatment and negative symptoms could contribute to fatigue in people in schizophrenia.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: