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Drug Metabolism and Antidepressant (METADEP)

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ClinicalTrials.gov Identifier: NCT02438072
Recruitment Status : Unknown
Verified May 2015 by Celia Lloret-Linares, University Hospital, Geneva.
Recruitment status was:  Recruiting
First Posted : May 8, 2015
Last Update Posted : May 8, 2015
Sponsor:
Information provided by (Responsible Party):
Celia Lloret-Linares, University Hospital, Geneva

Brief 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. During one year, patients receiving antidepressant will be included in tis prospective clinical, naturalistic and descriptive pilot study.

Condition or disease Intervention/treatment Phase
Depression Drug: Omeprazole (10 mg, A02BC01) Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Cocktail Phenotypic Approach to Explore Antidepressant Pharmacokinetic Variability: a Pilot Study
Study Start Date : December 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Overall population Drug: Omeprazole (10 mg, A02BC01)
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
Other Names:
  • Flurbiprofen (10 mg, M01AE09)
  • Dextromethorphan (10 mg, R05DA09)
  • Midazolam (1 mg, N05CD08)
  • Fexofenadine (25mg, R06AX26 )
  • Bupropion (20 mg, N06AX12)
  • Caffeine (50 mg, N06BC01)




Primary Outcome Measures :
  1. CYP1A2 activity [ Time Frame: >two hours after an oral intake of the cocktail probe drugs ]
    paraxanthine/caffeine

  2. CYP2B6 activity [ Time Frame: >two hours after an oral intake of the cocktail probe drugs ]
    4-hydroxybupropion/ bupropion

  3. CYP2D6 activity [ Time Frame: >two hours after an oral intake of the cocktail probe drugs ]
    dextrorphan / dextromethorphan

  4. CYP2C9 activity [ Time Frame: >two hours after an oral intake of the cocktail probe drugs ]
    4-hydroxyflurbiprofen/ flurbiprofen

  5. CYP2C19 activity [ Time Frame: >two, three and six hours after an oral intake of the cocktail probe drugs ]
    5-hydroxyomeprazole/ omeprazole

  6. CYP3A4 activity [ Time Frame: >two hours after an oral intake of the cocktail probe drugs ]
    1-hydroxymidazolam/ midazolam

  7. P-gp activity [ Time Frame: >two, three and six hours after an oral intake of the cocktail probe drugs ]
    Limited sampling fexofenadine AUC


Secondary Outcome Measures :
  1. Antidepressant Concentration [ Time Frame: almost 6 weeks after the last treatment change ]
  2. Antidepressant tolerance [ Time Frame: almost 6 weeks after the last treatment change ]
    FISBER test

  3. Antidepressant efficacy [ Time Frame: almost 6 weeks after the last treatment change ]
    Tests: MADRS, Hamilton, QIDS-16



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Male and female aged from 18 to 70 years
  3. Volunteers to participate to the study
  4. Understanding of French language and able to give a written inform consent.

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438072


Contacts
Contact: Celia Lloret-Linares, MD, PhD 0041 79 55 36 389 Celia.LloretLinares@hcuge.ch

Locations
Switzerland
Hôpitaux Universitaires de Genève Recruiting
Genève, Switzerland, 1205
Contact: celia Lloret-Linares, MD, PhD    0041 79 55 36 389    celia.LloretLinares@hcuge.ch   
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Celia Lloret-Linares, MD, PhD Hôpitaux universitaires de Genève

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celia Lloret-Linares, Doctor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02438072     History of Changes
Other Study ID Numbers: CER-14051
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

Keywords provided by Celia Lloret-Linares, University Hospital, Geneva:
antidepressive agent
drug metabolism
CYP450
P-glycoprotein
Phenotypic study

Additional relevant MeSH terms:
Antidepressive Agents
Omeprazole
Flurbiprofen
Dextromethorphan
Fexofenadine
Psychotropic Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors