DSM-5 SchizophreniaCroyAid-SCZNCT03471013
Impact of Caregiver Beliefs on Adherence to Antipsychotic Medications in Patients With Schizophrenia
An observational study of DSM-5 Schizophrenia, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Only one third of patients with schizophrenia are observant to their treatment knowing that the lack of adherence to treatment is one of the most important predictors of relapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DSM-5 Schizophrenia
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2018to 2 Feb 2026
- 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: Patients with a diagnosis of scizophrenia
Who may be able to join
- Patient over 18 years old
- With a diagnosis of schizophrenia according to DSM-5 criteria
- Accompanied by his main caregiver, who will be able to complete the questionnaires after having signed the information form.
- Treated with one or more antipsychotics.
- Able to complete the questionnaires related to the protocol
- Having agreed to sign the information form.
Who cannot join
- Not understanding French, unable to answer questions linguistically
- Presenting an organic pathology and / or cognitive deterioration likely to hinder a good understanding of the interview
- Having already participated in the study
- presenting disorders related to the use of substances of severe intensity (such as acute intoxication, withdrawal syndrome or any state of delirium)
Trial locations and contacts
1 site in 1 country.
About this study
Only one third of patients with schizophrenia are observant to their treatment knowing that the lack of adherence to treatment is one of the most important predictors of relapse.
Recent work shows that the erroneous or negative beliefs of patients with schizophrenia regarding antipsychotic treatment are associated with poor compliance.
Read more
The hypothesis is that negative beliefs about the antipsychotic treatment of caregivers of patients with schizophrenia may be associated with a higher risk of poor compliance compared to caregivers with positive beliefs about treatment.
The primary purpose is to explore the correlation between caregiver beliefs about treatment and patient compliance, taking into account the level of caregiver-patient link.
Read the detailed description
Non-interventional cross-sectional exploratory study with a single visit for patients with schizophrenia and their caregivers, who agreed to participate in the protocol.
- Conditions
- DSM-5 Schizophrenia
- Keywords
- schizophrenia, beliefs, caregiver
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients and caregivers | Patients suffering from schizophrenia accompanied by their caregiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the correlation between caregiver beliefs about treatment and patient compliance
The caregiver beliefs are evaluated by the Beliefs about Medicines Questionnaire, the patient compliance is evaluated by the investigator with Behaviourally Anchored Rating Scales and by the patient him-self with Morisky Medication Adherence Scale, and the level of caregiver-patient link is evaluated with Involvement Evaluation Questionnaire.
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start20 Mar 2018
- Primary completion10 Jul 2025
- Study completion2 Feb 2026
Why it stopped: difficulty of recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DSM-5 SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ludovic SAMALIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471013
- Sponsor's protocol ID
- CHU-384
- Other IDs
- 2017-A02271-52
- Acronym
- CroyAid-SCZ
- Status last verified
- Feb 2026
- First submitted
- 13 Mar 2018
- Last updated
- 11 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Caregiver Beliefs on Adherence to Antipsychotic Medications in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT03471013
- Acronym / sponsor ID
- CroyAid-SCZ / CHU-384
- Conditions
- DSM-5 Schizophrenia
- Keywords
- schizophrenia, beliefs, caregiver
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: difficulty of recruitement
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 20 Mar 2018 (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.
Only one third of patients with schizophrenia are observant to their treatment knowing that the lack of adherence to treatment is one of the most important predictors of relapse.
Recent work shows that the erroneous or negative beliefs of patients with schizophrenia regarding antipsychotic treatment are associated with poor compliance.
The hypothesis is that negative beliefs about the antipsychotic treatment of caregivers of patients with schizophrenia may be associated with a higher risk of poor compliance compared to caregivers with positive beliefs about treatment.
The primary purpose is to explore the correlation between caregiver beliefs about treatment and patient compliance, taking into account the level of caregiver-patient link.
Detailed description
Non-interventional cross-sectional exploratory study with a single visit for patients with schizophrenia and their caregivers, who agreed to participate in the protocol.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients and caregivers | – | –Patients suffering from schizophrenia accompanied by their caregiver |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of scizophrenia
Key inclusion criteria (6 listed)
- Patient over 18 years old
- With a diagnosis of schizophrenia according to DSM-5 criteria
- Accompanied by his main caregiver, who will be able to complete the questionnaires after having signed the information form.
- Treated with one or more antipsychotics.
- Able to complete the questionnaires related to the protocol
Key exclusion criteria (4 listed)
- Not understanding French, unable to answer questions linguistically
- Presenting an organic pathology and / or cognitive deterioration likely to hinder a good understanding of the interview
- Having already participated in the study
- presenting disorders related to the use of substances of severe intensity (such as acute intoxication, withdrawal syndrome or any state of delirium)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the correlation between caregiver beliefs about treatment and patient compliance
Time frame: At day 1
The caregiver beliefs are evaluated by the Beliefs about Medicines Questionnaire, the patient compliance is evaluated by the investigator with Behaviourally Anchored Rating Scales and by the patient him-self with Morisky Medication Adherence Scale, and the level of caregiver-patient link is evaluated with Involvement Evaluation Questionnaire.
Results and safety
The study was stopped early (reason given: difficulty of recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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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.
Ludovic SAMALIN principal investigator
University Hospital, Clermont-Ferrand
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 DSM-5 Schizophrenia, run by University Hospital, Clermont-Ferrand 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 6 inclusion and 4 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 11 Feb 2026. 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: difficulty of recruitement). 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?
Assessment of the correlation between caregiver beliefs about treatment and patient compliance (time frame: At day 1). 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 11 Feb 2026.