DepressionPharmacogenetiNCT02856477
Pharmacogenetic and Antidepressant Treatment in Elderly
A study testing urine analysis in people with Depression, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The study aims to assess the therapeutic benefits of the adaptation of the antidepressant dose to the metabolic capacity (cytochrome P450 2D6) of elderly depressed patients. Therapeutic benefits are evaluated through the enhancement of efficiency, decrease of the action time and the after effects. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Depression
- What is being tested?
- urine analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2007to Apr 2016
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- current major depressive disorder
- antidepressant treatment
Who cannot join
- dextromethorphan contra-indication
- other psychiatric disorder
- kidney failure
- liver failure mini mental State Examination (MMSE)<18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacogenetic in the Therapeutic Strategy in Depressed Elderly
The study aims to assess the therapeutic benefits of the adaptation of the antidepressant dose to the metabolic capacity (cytochrome P450 2D6) of elderly depressed patients.
Therapeutic benefits are evaluated through the enhancement of efficiency, decrease of the action time and the after effects.
- Conditions
- Depression
- Being tested
- urine analysis
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine analysisBiological
a sample of urine is collected during 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| adapted treatment | Experimental | the treatment dose is adapted to the metabolic capacity of the patient. intervention: urine analysis Receives: Biological: urine analysis |
| non-adaptated treatment | Experimental | the treatment dose is adapted to the metabolic capacity of the patient. intervention: urine analysis Receives: Biological: urine analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient remission
remission is defined by a Montgomery and asberg depression rating (MADRS) score<10.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startNov 2007
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- pierre Vandel, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856477
- Sponsor's protocol ID
- R/2007/32
- Acronym
- Pharmacogeneti
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic in the Therapeutic Strategy in Depressed Elderly
- ClinicalTrials.gov ID
- NCT02856477
- Acronym / sponsor ID
- Pharmacogeneti / R/2007/32
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Aug 2016 (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.
The study aims to assess the therapeutic benefits of the adaptation of the antidepressant dose to the metabolic capacity (cytochrome P450 2D6) of elderly depressed patients.
Therapeutic benefits are evaluated through the enhancement of efficiency, decrease of the action time and the after effects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adapted treatment | Experimental | Biological: urine analysisthe treatment dose is adapted to the metabolic capacity of the patient. intervention: urine analysis |
| non-adaptated treatment | Experimental | Biological: urine analysisthe treatment dose is adapted to the metabolic capacity of the patient. intervention: urine analysis |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- current major depressive disorder
- antidepressant treatment
Key exclusion criteria (4 listed)
- dextromethorphan contra-indication
- other psychiatric disorder
- kidney failure
- liver failure mini mental State Examination (MMSE)<18
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 |
|---|---|---|
| urine analysisa sample of urine is collected during 8 hours. | Biological | adapted treatment, non-adaptated treatment |
Primary outcome
patient remission
Time frame: 6 months
remission is defined by a Montgomery and asberg depression rating (MADRS) score<10.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- 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.
pierre Vandel, MD PhD 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 urine analysis in people with 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 2 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 5 Aug 2016. 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. 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?
patient remission (time frame: 6 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 5 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.