Unipolar DepressionPREDICTageNCT03227133
Oral Fluency and the Response to Antidepressant Therapy in the Elderly With a Unipolar Depressive Episode
A study testing Neuropsychological evaluations, Psychiatric interview and Cardiovascular risk assessment in people with Unipolar Depression, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The study focuses on the identification of clinical, physiological and morphological markers that could predict the response to antidepressant in elderly suffering from unipolar depressive disorder. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- Neuropsychological evaluations, Psychiatric interview and Cardiovascular risk assessment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 23 Dec 2016to 23 Jun 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Depressive episode according to DSM-5 criteria
- Unipolar depression
- MADRS ≥ 20
- Antidepressive treatment (Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors)
Who cannot join
- Other comorbid mental disorders (bipolar disorder, schizophrenia, recent addiction < 3 months except for tobacco)
- Depression with psychotic features
- Serious unstabilized somatic illness
- Protected persons
- Dementia suspected at the time of enrollment
Trial locations and contacts
1 site in 1 country.
Julie Monnin, PhD contact
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Besançon
Besançon, 25000
Julie Monnin, PhD, jmonnin@chu-besancon.fr
Caroline Masse-Sibille, MD
About this study
Official title: An Exploratory Study of the Use of Oral Fluency as a Predictive Tool for the Antidepressant Response of Elderly With Unipolar Depressive Disorder
The study focuses on the identification of clinical, physiological and morphological markers that could predict the response to antidepressant in elderly suffering from unipolar depressive disorder.
- Conditions
- Unipolar Depression
- Being tested
- Neuropsychological evaluations, Psychiatric interview, Cardiovascular risk assessment
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological evaluationsOther
Neuropsychological evaluations including oral fluency, performed specifically for the study
Psychiatric interviewOther
Cardiovascular risk assessmentOther
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Psychiatric interview, Neuropsychological evaluations, cardiovascular risk assessment Receives: Other: Neuropsychological evaluations; Other: Psychiatric interview; Other: Cardiovascular risk assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the verbal fluency test score to predict the response to antidepressive treatment
verbal fluency is assessed during the neuropsychological assessment
Measured: week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start23 Dec 2016
- Primary completionJun 2019 (estimated)
- Study completion23 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Masse-Sibille, MD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227133
- Sponsor's protocol ID
- P/2016/297
- Acronym
- PREDICTage
- Status last verified
- Jul 2017
- First submitted
- 21 Jul 2017
- Last updated
- 24 Jul 2017
- 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 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of the Use of Oral Fluency as a Predictive Tool for the Antidepressant Response of Elderly With Unipolar Depressive Disorder
- ClinicalTrials.gov ID
- NCT03227133
- Acronym / sponsor ID
- PREDICTage / P/2016/297
- Conditions
- Unipolar Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 23 Dec 2016 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- 23 Jun 2019 (estimated)
- First posted
- 24 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.
The study focuses on the identification of clinical, physiological and morphological markers that could predict the response to antidepressant in elderly suffering from unipolar depressive disorder.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Other: Neuropsychological evaluations, Other: Psychiatric interview, Other: Cardiovascular risk assessmentPsychiatric interview, Neuropsychological evaluations, cardiovascular risk assessment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Depressive episode according to DSM-5 criteria
- Unipolar depression
- MADRS ≥ 20
- Antidepressive treatment (Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors)
Key exclusion criteria (5 listed)
- Other comorbid mental disorders (bipolar disorder, schizophrenia, recent addiction < 3 months except for tobacco)
- Depression with psychotic features
- Serious unstabilized somatic illness
- Protected persons
- Dementia suspected at the time of enrollment
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 |
|---|---|---|
| Neuropsychological evaluationsNeuropsychological evaluations including oral fluency, performed specifically for the study | Other | Single arm |
| Psychiatric interview | Other | Single arm |
| Cardiovascular risk assessment | Other | Single arm |
Primary outcome
Ability of the verbal fluency test score to predict the response to antidepressive treatment
Time frame: week 10
verbal fluency is assessed during the neuropsychological assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- 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.
Julie Monnin, PhD contact
Caroline Masse-Sibille, MD principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological evaluations, Psychiatric interview and Cardiovascular risk assessment in people with Unipolar Depression, run by Centre Hospitalier Universitaire de Besancon 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 4 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: status not confirmed, as of the sponsor's last update on 24 Jul 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Monnin, PhD (jmonnin@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of the verbal fluency test score to predict the response to antidepressive treatment (time frame: week 10). 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 24 Jul 2017.