AzTrials
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DepressionMETADEPNCT02438072

Drug Metabolism and Antidepressant

A study testing Omeprazole (10 mg, A02BC01) in people with Depression, run by University Hospital, Geneva at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

We propose here to explore systematically the association between drug-metabolizing enzymes activity assessed by a phenotypical approach and antidepressant plasma concentration, efficacy and tolerance in the clinical setting. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Depression
What is being tested?
Omeprazole (10 mg, A02BC01)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSwitzerland
Study dates
Dec 2014to Dec 2015
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with clinical diagnosis of depression and decision to change antidepressant therapy (augmentation or switch) OR Patients with clinical diagnosis of depression and stability of prescription since almost 6 weeks
  • Male and female aged from 18 to 70 years
  • Volunteers to participate to the study
  • Understanding of French language and able to give a written inform consent.

Who cannot join

  • Renal or hepatic impairment (Clearance below 60mL/min, AST or ALT over 3N) Sensitivity to any of the substrate drugs used ECG showing long QT interval (>0.46sec) No antidepressant dosage available Current pregnancy or desire to get pregnant
  • Criteria to perform V1 Sufficient compliance between V0 and V1 Six weeks period without change in antidepressant therapy

Trial locations and contacts

1 site in 1 country.

Celia Lloret-Linares, MD, PhD contact

0041 79 55 36 389

Celia.LloretLinares@hcuge.ch

Switzerland1 site, 1 recruiting

  • Hôpitaux Universitaires de Genève

    Geneva, 1205

    celia Lloret-Linares, MD, PhD, 0041 79 55 36 389, celia.LloretLinares@hcuge.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Cocktail Phenotypic Approach to Explore Antidepressant Pharmacokinetic Variability: a Pilot Study

We propose here to explore systematically the association between drug-metabolizing enzymes activity assessed by a phenotypical approach and antidepressant plasma concentration, efficacy and tolerance in the clinical setting. During one year, patients receiving antidepressant will be included in tis prospective clinical, naturalistic and descriptive pilot study.

Read the detailed description
  • Objectives To describe drug metabolism variability in depressive patients using a phenotypic approach
  • Study design Prospective, clinical, naturalistic, descriptive study During a consultation with their clinician, depressive patients will receive information.

During the visit V0 with an investigator: patients will be included:

  • Verification of inclusion and non inclusion criteria
  • Reminder participation conditions
  • Inclusion, signature of consent
  • Collection of clinical and demographic features Between V0 and V1, for patients with change in antidepressant therapy, will take place telephone interviews every two weeks, conducted by the clinician to evaluate treatment depression response (tolerance and efficacy)

During the visit V1, will take place:

  • Phenotypic study
  • Genetic study
  • Dosage of current antidepressant drug
  • Clinical evaluation: efficacy and tolerance
  • Number of patients During one year, the protocol will be proposed to all patients with depression and decision of change in antidepressant therapy, and all patients with stability od prescription since almost 6 weeks. The inclusion of approximately 100 patients is expected.
  • Name of the finished product Zyban®, Froben®, Antra®, Bexine®, Dormicum® Telfast®
  • Name of the active substance Omeprazole (10 mg, A02BC01) Caffeine (50 mg, N06BC01) Flurbiprofen (10 mg, M01AE09) Dextromethorphan (10 mg, R05DA09) Midazolam (1 mg, N05CD08) Fexofenadine (25mg, R06AX26 ) Bupropion (20 mg, N06AX12)
  • Duration of treatment One time during the study, one day (Visit 1)
  • Time plan of research -Duration for the patient: The study will stop when the patient has performed the V1 study Minimal delay between V0 and V1: 6 weeks (5-7 weeks) : for patient with decision to change the treatment, 5 days for patients with stability of treatment since almost 6 weeks.

Maximal delay of participation for the patient: 4 months even when V1 was not performed

-Overall duration of inclusion: one year Maximal overall duration of the study: 12 months+4 months= 16 months Maximal duration for the analytical study since the beginning of the study= 16 months+6 months: 22 months.

Maximal delay for communication of the results: 2 years after the beginning of the study

Conditions
Depression
Being tested
Omeprazole (10 mg, A02BC01)
Keywords
antidepressive agent, drug metabolism, CYP450, P-glycoprotein, Phenotypic study
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omeprazole (10 mg, A02BC01)Drug

    Also called Flurbiprofen (10 mg, M01AE09), Dextromethorphan (10 mg, R05DA09), Midazolam (1 mg, N05CD08), Fexofenadine (25mg, R06AX26 )

    The cocktail of drug substrates will be given one time, one day during the study, to explore the activity of CYP 1A2, 2B6, 2C9, 2C19, 3A4, 2D6, and the P-gp

Study groups in NCT02438072
Study groupRoleWhat they receive
Overall populationOtherNot described
Receives: Drug: Omeprazole (10 mg, A02BC01)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CYP1A2 activity

    paraxanthine/caffeine

    Measured: >two hours after an oral intake of the cocktail probe drugs

  2. CYP2B6 activity

    4-hydroxybupropion/ bupropion

    Measured: >two hours after an oral intake of the cocktail probe drugs

  3. CYP2D6 activity

    dextrorphan / dextromethorphan

    Measured: >two hours after an oral intake of the cocktail probe drugs

  4. CYP2C9 activity

    4-hydroxyflurbiprofen/ flurbiprofen

    Measured: >two hours after an oral intake of the cocktail probe drugs

  5. CYP2C19 activity

    5-hydroxyomeprazole/ omeprazole

    Measured: >two, three and six hours after an oral intake of the cocktail probe drugs

  6. CYP3A4 activity

    1-hydroxymidazolam/ midazolam

    Measured: >two hours after an oral intake of the cocktail probe drugs

  7. P-gp activity

    Limited sampling fexofenadine AUC

    Measured: >two, three and six hours after an oral intake of the cocktail probe drugs

Secondary outcomes (3)

  1. Antidepressant Concentration

    Measured: almost 6 weeks after the last treatment change

  2. Antidepressant tolerance

    FISBER test

    Measured: almost 6 weeks after the last treatment change

  3. Antidepressant efficacy

    Tests: MADRS, Hamilton, QIDS-16

    Measured: almost 6 weeks after the last treatment change

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionDec 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02438072
Sponsor's protocol ID
CER-14051
Acronym
METADEP
Status last verified
May 2015
First submitted
30 Apr 2015
Last updated
8 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • Bosilkovska M, Samer CF, Deglon J, Rebsamen M, Staub C, Dayer P, Walder B, Desmeules JA, Daali Y. Geneva cocktail for cytochrome p450 and P-glycoprotein activity assessment using dried blood spots. Clin Pharmacol Ther. 2014 Sep;96(3):349-59. doi: 10.1038/clpt.2014.83. Epub 2014 Apr 10.

    PubMed 24722393

  • Hall-Flavin DK, Winner JG, Allen JD, Carhart JM, Proctor B, Snyder KA, Drews MS, Eisterhold LL, Geske J, Mrazek DA. Utility of integrated pharmacogenomic testing to support the treatment of major depressive disorder in a psychiatric outpatient setting. Pharmacogenet Genomics. 2013 Oct;23(10):535-48. doi: 10.1097/FPC.0b013e3283649b9a.

    PubMed 24018772

  • Lloret-Linares C, Bosilkovska M, Daali Y, Gex-Fabry M, Heron K, Bancila V, Michalopoulos G, Perroud N, Richard-Lepouriel H, Aubry JM, Desmeules J, Besson M. Phenotypic Assessment of Drug Metabolic Pathways and P-Glycoprotein in Patients Treated With Antidepressants in an Ambulatory Setting. J Clin Psychiatry. 2018 Mar/Apr;79(2):16m11387. doi: 10.4088/JCP.16m11387.

    PubMed 29570971

Questions about this trial

What is this clinical trial studying?

A study testing Omeprazole (10 mg, A02BC01) in people with Depression, run by University Hospital, Geneva at 1 site in Switzerland.

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 2 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 8 May 2015. 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 Switzerland. 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 Celia Lloret-Linares, MD, PhD (0041 79 55 36 389, Celia.LloretLinares@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CYP1A2 activity (time frame: >two hours after an oral intake of the cocktail probe drugs). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02438072, which also lists 3 linked publications.

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 8 May 2015.

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