SchizophreniaNCT03209778
Involuntary Memories Investigation in Schizophrenia
A study testing Patients with Schizophrenia in people with Schizophrenia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Patients with schizophrenia suffer from autobiographical memory disorders. Patients have difficulty to remember vividly personal past events when they are specifically asked for. Indeed, this task requires a good executive functioning to retrieve precise information stored in long term memory. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Patients with Schizophrenia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2017to 15 Dec 2019
- Phase
- Interventional
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - for patients only
- male or female
- age limits : 18-55 years old
- under the protection of health insurance
- who have signed up the consent form
- schizophrenia or schizo-affective disorder according to the DSM-5 criteria (APA, 2013).
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- clinically stable for at least 2 months
- patients under guardianship or curatorship need agreement of their legal representative
- informed of the results of prior medical examination for controls only
- male or female
- age limits : 18-55 years old
- under the protection of health insurance
- who have sign up the consent form
- recruited from the general population and matched on gender, age years of schooling
- no psychiatric history (DSM-5)
Who cannot join
- for both patients and controls
- current severe or unstable somatic illness
- neurological history (brain injury > 15 minutes loss of consciousness , epilepsia, brain surgery…)
- current substance use disorder (DSM-5)
- current major depressive disorder (CDSS,BDI, HDRS)
- mental retardation (IQ < 70, WAIS-4, f-NART)
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- history of general anesthesia 3 months prior to the experiment
- pregnancy declared by the subject
- breast feeding
- current legal control
- in emergency situation
- included during exclusion period in another experiment
- for controls only
- taking of antipsychotic drugs for the 3 weeks prior to inclusion
- under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Patients with schizophrenia suffer from autobiographical memory disorders. Patients have difficulty to remember vividly personal past events when they are specifically asked for. Indeed, this task requires a good executive functioning to retrieve precise information stored in long term memory. Interestingly, executive functioning has been showed impaired in schizophrenia and studies showed that their autobiographical memory impairments were directed related to their executive dysfunction.
Yet, in daily life people remember more often autobiographical memories spontaneously, without trying voluntarily to recall them.
Read more
In that case, the involuntary recall of personal past events is much less sustained by executive functioning.
In this protocol the investigators would like to investigate and compare subjective characteristics of involuntary and voluntary autobiographical memories in order to highlight the role of executive dysfunction in patients' autobiographical memory impairments.
- Conditions
- Schizophrenia
- Being tested
- Patients with Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with SchizophreniaOther
Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Control participants without psychiatric nor neurological history Receives: Other: Patients with Schizophrenia |
| Patients with Schizophrenia | Experimental | Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria Receives: Other: Patients with Schizophrenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autobiographical subjective score taking into account memories vividness and specifity
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start29 Sep 2017
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Why it stopped: The research was stopped because of recruitment difficulties at the end of the study due to a high drop-out rate for one of the two tasks included in the protocol.
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.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209778
- Sponsor's protocol ID
- 6620
- Status last verified
- Sep 2021
- First submitted
- 3 Jul 2017
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involuntary Memories Investigation in Schizophrenia
- ClinicalTrials.gov ID
- NCT03209778
- Acronym / sponsor ID
- 6620
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The research was stopped because of recruitment difficulties at the end of the study due to a high drop-out rate for one of the two tasks included in the protocol.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 6 Jul 2017 (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.
Patients with schizophrenia suffer from autobiographical memory disorders. Patients have difficulty to remember vividly personal past events when they are specifically asked for. Indeed, this task requires a good executive functioning to retrieve precise information stored in long term memory. Interestingly, executive functioning has been showed impaired in schizophrenia and studies showed that their autobiographical memory impairments were directed related to their executive dysfunction.
Yet, in daily life people remember more often autobiographical memories spontaneously, without trying voluntarily to recall them.
In that case, the involuntary recall of personal past events is much less sustained by executive functioning.
In this protocol the investigators would like to investigate and compare subjective characteristics of involuntary and voluntary autobiographical memories in order to highlight the role of executive dysfunction in patients' autobiographical memory impairments.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Patients with SchizophreniaControl participants without psychiatric nor neurological history |
| Patients with Schizophrenia | Experimental | Other: Patients with SchizophreniaPatients with schizophrenia or schizoaffective disorder according to DSM-V criteria |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- - for patients only
- male or female
- age limits : 18-55 years old
- under the protection of health insurance
- who have signed up the consent form
Key exclusion criteria (15 listed)
- for both patients and controls
- current severe or unstable somatic illness
- neurological history (brain injury > 15 minutes loss of consciousness , epilepsia, brain surgery…)
- current substance use disorder (DSM-5)
- current major depressive disorder (CDSS,BDI, HDRS)
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 |
|---|---|---|
| Patients with SchizophreniaPatients with schizophrenia or schizoaffective disorder according to DSM-V criteria | Other | Control group, Patients with Schizophrenia |
Primary outcome
Autobiographical subjective score taking into account memories vividness and specifity
Time frame: 8 months
Results and safety
The study was stopped early (reason given: The research was stopped because of recruitment difficulties at the end of the study due to a high drop-out rate for one of the two tasks included in the protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients with Schizophrenia in people with Schizophrenia, run by University Hospital, Strasbourg, France 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 15 inclusion and 15 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 20 Sep 2021. 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: The research was stopped because of recruitment difficulties at the end of the study due to a high drop-out rate for one of the two tasks included in the protocol.). 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?
Autobiographical subjective score taking into account memories vividness and specifity (time frame: 8 months). 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 20 Sep 2021.