SchizophreniaNCT01689181
Apathy in Schizophrenia
An observational study of Schizophrenia and Apathy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Apathy, defined as a quantitative reduction of voluntary, goal-directed behaviours (GDB), is a core component of negative symptoms. It has been suggested that the physiopathology of apathy is not a single entity but may be multiple, depending on which specific process or macrofunction is disrupted during completion of… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Apathy
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to 5 Jun 2013
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: schizophrenic patients: * outpatients of the Corentin Celton psychiatric service * inpatients of the Corentin Celton Day Hospital Unit healthy volunteers: community
Who may be able to join
- Male or Female aged 20 to 55 years old included
- Under French public assurance system
- Male or Female aged 20 to 55 years old included
- Under French public assurance system
- diagnosis of schizophrenia according to the DSM-IV R criteria
- Duration of illness > 5 years
- clinical stability during the past 2 months (defined as no treatment modification or hospitalisation 2 months prior evaluation)
Who cannot join
- Personal history of neurological disorders
- Personal history of head injury
- Alcohol or substance abuse
- Under psychotropic drug
- Contraindication for MRI
- Schizo-affective disorder
Show all 10Show fewer
- Personal history of neurological disorders
- Personal history of head injury
- Alcohol or substance abuse
- Contraindication for MRI
Trial locations and contacts
1 site in 1 country.
France1 site
INSERM MEDU 945, Centre de Recherche-Institut du Cerveau et de la Moelle (CR-ICM), Hôpital de la Pitié Salpétrière
Paris, 75013
About this study
Official title: L'apathie Dans La Schizophrénie: Étude Neuropsychologique Et Anatomique
Apathy, defined as a quantitative reduction of voluntary, goal-directed behaviours (GDB), is a core component of negative symptoms. It has been suggested that the physiopathology of apathy is not a single entity but may be multiple, depending on which specific process or macrofunction is disrupted during completion of GDB. In line with this notion, Levy and Dubois proposed dividing apathic syndromes into three subtypes of disrupted processing: 'a-motivation', 'cognitive inertia', and 'uncoupling'. In schizophrenia, apathy has been associated with executive dysfunction, functional impairment and poor outcome. However, the neurobiological underpinnings of apathy in schizophrenia are poorly understood.
Primary objective: confirm that chronic schizophrenic patients are apathic compared to healthy volunteers
Read more
Secondary objectives:
- investigate if apathy is related to a particular aspect of the disease (i.e. negative, positive symptomatology and/or deficit form)
- investigate if apathy correlates with executive dysfunction
- investigate if apathy is associated with a specific mechanism using an experimental task specially designed to investigate the different mechanism (i.e. 'a-motivation', 'cognitive inertia', and 'uncoupling')
- investigate if there is a volumetric abnormality affecting the executive system in apathic schizophrenic patients
- link these eventual volumetric abnormalities to prefrontal cortex-basal ganglia circuits according to a specific subtype of apathy in the apathic schizophrenic group
- Conditions
- Schizophrenia, Apathy
- Medical subject headings
- Schizophrenia, Lethargy
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 |
|---|---|---|
| chronic schizophrenic patients | Not described | |
| healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
apathy as measured by Starkstein's Apathy Evaluation Scale
Measured: baseline
Secondary outcomes (3)
neuropsychological performance
- Global mental efficience: Mill Hill B and Raven's progressive matrices 38
- Executive functioning:Modified Card Sorting Test, Trail Making A and B, Stroop Test, Verbal Fluences, Frontal Assessment Battery (FAB, Dubois et al., 2000)
- Social and Emotional Cognition: SEA (Social and Emotional Evaluation (SEA, Funkiewiez et al., 2012)
- Working memory (Grober and Buschke - 16 items, digit span)
- Instrumental functions: Rey Osterrieth Complex figure)
Measured: baseline
clinical assessment (for patients only)
scores on evaluation scales (PANSS, SAPS, SANS, CDS, SDS)
Measured: baseline
volumetric brain abnormalities
voxel based morphometry
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startJun 2012
- Primary completion5 Jun 2013
- Study completion5 Jun 2013
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 Institut National de la Santé Et de la Recherche Médicale, 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Richard Levy, MD, Principal investigator, INSERM MEDU 945, Centre de Recherche-Institut du Cerveau et de la Moelle (CR-ICM), Hôpital de la Pitié Salpétrière, 75013 Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689181
- Sponsor's protocol ID
- C11-39
- Other IDs
- 2011-A01610-41
- Status last verified
- Jan 2025
- First submitted
- 7 Sep 2012
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L'apathie Dans La Schizophrénie: Étude Neuropsychologique Et Anatomique
- ClinicalTrials.gov ID
- NCT01689181
- Acronym / sponsor ID
- C11-39
- Conditions
- Schizophrenia, Apathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Jun 2012 (actual)
- Primary completion
- 5 Jun 2013 (actual)
- Study completion
- 5 Jun 2013 (actual)
- First posted
- 21 Sep 2012 (estimated)
- 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.
Apathy, defined as a quantitative reduction of voluntary, goal-directed behaviours (GDB), is a core component of negative symptoms. It has been suggested that the physiopathology of apathy is not a single entity but may be multiple, depending on which specific process or macrofunction is disrupted during completion of GDB. In line with this notion, Levy and Dubois proposed dividing apathic syndromes into three subtypes of disrupted processing: 'a-motivation', 'cognitive inertia', and 'uncoupling'. In schizophrenia, apathy has been associated with executive dysfunction, functional impairment and poor outcome. However, the neurobiological underpinnings of apathy in schizophrenia are poorly understood.
Primary objective: confirm that chronic schizophrenic patients are apathic compared to healthy volunteers
Secondary objectives:
- investigate if apathy is related to a particular aspect of the disease (i.e. negative, positive symptomatology and/or deficit form)
- investigate if apathy correlates with executive dysfunction
- investigate if apathy is associated with a specific mechanism using an experimental task specially designed to investigate the different mechanism (i.e. 'a-motivation', 'cognitive inertia', and 'uncoupling')
- investigate if there is a volumetric abnormality affecting the executive system in apathic schizophrenic patients
- link these eventual volumetric abnormalities to prefrontal cortex-basal ganglia circuits according to a specific subtype of apathy in the apathic schizophrenic group
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic schizophrenic patients | – | – |
| healthy volunteers | – | – |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- schizophrenic patients: * outpatients of the Corentin Celton psychiatric service * inpatients of the Corentin Celton Day Hospital Unit healthy volunteers: community
Key inclusion criteria (7 listed)
- Male or Female aged 20 to 55 years old included
- Under French public assurance system
- Male or Female aged 20 to 55 years old included
- Under French public assurance system
- diagnosis of schizophrenia according to the DSM-IV R criteria
Key exclusion criteria (10 listed)
- Personal history of neurological disorders
- Personal history of head injury
- Alcohol or substance abuse
- Under psychotropic drug
- Contraindication for MRI
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
apathy as measured by Starkstein's Apathy Evaluation Scale
Time frame: baseline
3 secondary outcomes
neuropsychological performance
Time frame: baseline
clinical assessment (for patients only)
Time frame: baseline
volumetric brain abnormalities
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
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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.
Richard Levy, MD principal investigator
INSERM MEDU 945, Centre de Recherche-Institut du Cerveau et de la Moelle (CR-ICM), Hôpital de la Pitié Salpétrière, 75013 Paris
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 and Apathy, run by Institut National de la Santé Et de la Recherche Médicale, 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 23 Jan 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
apathy as measured by Starkstein's Apathy Evaluation Scale (time frame: baseline). 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 23 Jan 2025.