SchizophreniaFIZO-2NCT06397950
Correlates of Fatigue in People With Schizophrenia
An observational study of Schizophrenia, run by GCS CIPS at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Assessment of potential fatigue factors
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2024to 29 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be patients with schizophrenia, included in a psychosocial rehabilitation program.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Assessment of potential fatigue factors
- Keywords
- Trait fatigue, Correlates, Physical activity, Sleep, Iatrogenic
- Medical subject headings
- Schizophrenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of potential fatigue factorsOther
3 visits will be carried out: V0: Inclusion V1: Familiarization visit V2: Experimental visit
V1
- Completion of MFI-20 questionnaire for familiarisation.
- Information about accelerometry and activity journal use will be delivered to the patient.
- The participant will be equipped with an accelerometer and asked to complete the activity journal for seven days.
V2
- Completion of questionnaires: MFI-20, GATS tobacco consumption questionnaire, caffeine consumption questionnaire, Fatigue Catastrophizing Scale, PSQI.
- Assessment of cognitive function: Sustained Attention to Response Task (SART), AX-Continuous Performance Task (AX-CPT) and verbal fluency test (animals and P categories).
- Assessment of physical evaluation: isometric evaluation of maximal handgrip strength, one-minute sit-to-stand test, isometric evaluation of maximal quadriceps strength, QIF test.
Negative symptoms will be assessed. Calf circumference will be measured for sarcopenia risk.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Schizophrenia | Patients are enrolled in a psychosocial rehabilitation program. Receives: Other: Assessment of potential fatigue factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength of predictive model of fatigue in schizophrenia
The aim is to determine the relative weight of the measured parameters to explain fatigue variance.
- Fatigue score obtained at the MFI-20 will be selected as the dependent variable.
- Muscle strength, muscle fatigue, functional abilities, risk of sarcopenia, sleep, cognition, antipsychotic treatment, smoking and coffee consumption, catastrophism, negative symptomatology, and physical activity and sedentary levels will be selected as independent variables.
- Variables will be entered in a multiple linear regression to establish a predictive model of fatigue.
Measured: 8 days : 7 days for sleep, sedentary and physical activity levels recording, plus the experimental session (V2) for all other variables
Secondary outcomes (1)
Characterization of fatigued people with schizophrenia
The aim is to identify which clinical parameters characterize the most fatigued patients (F-group) compared to those who report less fatigue (NF-group)
- Fatigued and less fatigued participants will be separated in two groups using the median score of the MFI-20 questionnaire as a cut point.
- For each of the variables (muscle strength, muscle fatigue, functional abilities, risk of sarcopenia, sleep, cognition, antipsychotic treatment, smoking and coffee consumption, catastrophism, negative symptomatology, and physical activity and sedentary levels), comparison of means (Student T test or Mann-Whitney U test depending on application conditions) will be used to compare F-group to NF-group.
Measured: 8 days : 7 days for sleep, sedentary and physical activity levels recording, plus the experimental session (V2) for all other variables
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start11 Oct 2024
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Why it stopped: Recruitment difficulties caused by a lack of eligible patients in the investigating center, calling into question the feasibility of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- GCS CIPS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel MULIN, Principal investigator, INICEA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397950
- Sponsor's protocol ID
- FIZO-2
- Acronym
- FIZO-2
- Status last verified
- Jul 2025
- First submitted
- 30 Apr 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlates of Fatigue in People With Schizophrenia
- ClinicalTrials.gov ID
- NCT06397950
- Acronym / sponsor ID
- FIZO-2 / FIZO-2
- Conditions
- Schizophrenia
- Keywords
- Trait fatigue, Correlates, Physical activity, Sleep, Iatrogenic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties caused by a lack of eligible patients in the investigating center, calling into question the feasibility of the study.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- GCS CIPSUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Schizophrenia | – | Other: Assessment of potential fatigue factorsPatients are enrolled in a psychosocial rehabilitation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be patients with schizophrenia, included in a psychosocial rehabilitation program.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of potential fatigue factors3 visits will be carried out: V0: Inclusion V1: Familiarization visit V2: Experimental visit V1 * Completion of MFI-20 questionnaire for familiarisation. * Information about accelerometry and activity journal use will be delivered to the patient. * The participant will be equipped with an accelerometer and asked to complete the activity journal for seven days. V2 * Completion of questionnaires: MFI-20, GATS tobacco consumption questionnaire, caffeine consumption questionnaire, Fatigue Catastrophizing Scale, PSQI. * Assessment of cognitive function: Sustained Attention to Response Task (SART), AX-Continuous Performance Task (AX-CPT) and verbal fluency test (animals and P categories). * Assessment of physical evaluation: isometric evaluation of maximal handgrip strength, one-minute sit-to-stand test, isometric evaluation of maximal quadriceps strength, QIF test. Negative symptoms will be assessed. Calf circumference will be measured for sarcopenia risk. | Other | Patients with Schizophrenia |
Primary outcome
Strength of predictive model of fatigue in schizophrenia
Time frame: 8 days : 7 days for sleep, sedentary and physical activity levels recording, plus the experimental session (V2) for all other variables
The aim is to determine the relative weight of the measured parameters to explain fatigue variance. * Fatigue score obtained at the MFI-20 will be selected as the dependent variable. * Muscle strength, muscle fatigue, functional abilities, risk of sarcopenia, sleep, cognition, antipsychotic treatment, smoking and coffee consumption, catastrophism, negative symptomatology, and physical activity and sedentary levels will be selected as independent variables. * Variables will be entered in a multiple linear regression to establish a predictive model of fatigue.
1 secondary outcome
Characterization of fatigued people with schizophrenia
Time frame: 8 days : 7 days for sleep, sedentary and physical activity levels recording, plus the experimental session (V2) for all other variables
Results and safety
The study was stopped early (reason given: Recruitment difficulties caused by a lack of eligible patients in the investigating center, calling into question the feasibility of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel MULIN principal investigator
INICEA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by GCS CIPS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties caused by a lack of eligible patients in the investigating center, calling into question the feasibility of the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength of predictive model of fatigue in schizophrenia (time frame: 8 days : 7 days for sleep, sedentary and physical activity levels recording, plus the experimental session (V2) for all other variables). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.