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Trial record 94 of 146 for:    ESCITALOPRAM AND Antagonists

Patient Stratification and Treatment Response Prediction in Neuropharmacotherapy Using Hybrid Positron Emmission Tomography/Magnetic Resconance Imaging (PET/MR)

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ClinicalTrials.gov Identifier: NCT02711215
Recruitment Status : Active, not recruiting
First Posted : March 17, 2016
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna

Brief Summary:

Selective serotonin reuptake inhibitors (SSRIs) raise serotonin (5-HT) in the synaptic cleft and are the current first line of pharmacological antidepressive treatment. Yet, there is a missing link between this first molecular step in their mechanism of action and observed clinical improvement. We have determined to establish a framework combining genuine molecular and functional imaging, i.e. hybrid pharmaco-PET/MR imaging, of the human serotonergic system in order to predict antidepressant treatment response.

Objectives:

  1. To predict antidepressant treatment response from data obtained using hybrid PET/MR with acute pharmacological challenge.
  2. To discriminate healthy from depressed subjects using this paradigm.
  3. To establish models connecting regional changes in occupancy of serotonin transporters (5-HTT) following citalopram infusion, with changes in brain activation and connectivity of major resting-state hub networks.

Design: Randomized, double-blind, placebo-controlled, cross-over mono-center study.

Materials and methods:

40 major depressed (MDD) and 40 healthy subjects will undergo 2 PET/MR scans on a 3T SIEMENS mMR Biograph scanner: 1. challenge with citalopram 8mg 2. placebo (saline). After structural imaging, functional MRI will be continuously acquired. [11C]DASB will be applied using a bolus + constant infusion paradigm to probe 5-HTT binding potentials and monitor 5-HTT occupancy with drug challenge, applied after 70min, in a single session. Scanning will be terminated 80min after challenge. MDD patients will receive subsequent escitalopram treatment with repeated evaluation of response for 3 months.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Diagnostic Test: PET/MR [11C]DASB Drug: Citalopram Drug: Escitalopram (Mirtazapine/Duloxetine/Venlafaxine) Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : May 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: PET/MR [11C]DASB
    2 PET/MR scans will be performed (placebo/citalopram - double-blind randomized cross-over)
    Other Name: Hybrid imaging, Molecular imaging, SERT binding potential
  • Drug: Citalopram
    8mg citalopram or placebo (saline) will be applied during PET/MR measurements in a double-blind randomized cross-over design
    Other Name: Seropram
  • Drug: Escitalopram (Mirtazapine/Duloxetine/Venlafaxine)
    After completion of imaging procedures, patients will receive treatment with escitalopram 10-20mg. In case of non-response, after 6 weeks, treatment will be switched to either Mirtazapine, Duloxetine or Venlafaxine
    Other Name: Cipralex
  • Drug: Placebo
    8mg citalopram or placebo (saline) will be applied during PET/MR measurements in a double-blind randomized cross-over design
    Other Name: Saline, NaCL


Primary Outcome Measures :
  1. Hamilton Depression Scale (HDRS) [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • General health based on medical history, physical examination and structured clinical interview for DSM-IV (SCID)
  • HAM-D≥18 (patients)
  • Willingness and competence to sign the informed consent form
  • Age 18 to 55 years

Exclusion Criteria:

  • Any medical, psychiatric or neurological illness (other than MDD)
  • Current or former psychopharmacological treatment
  • Current or former substance abuse
  • Pregnancy
  • Any implant or stainless steel graft or any other contraindications for MRI
  • Failure to comply with the study protocol or to follow the instructions of the investigating team
  • Participation in studies involving radiation exposure in the past 10 years.
  • Body mass index <17 or >30

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): NCT02711215


Locations
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Austria
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
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Responsible Party: Rupert Lanzenberger, Head of the Neuroimaging Labs, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02711215    
Other Study ID Numbers: 1.6_20180316
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Citalopram
Histamine H1 Antagonists
Histamine Antagonists
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin 5-HT3 Receptor Antagonists
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Duloxetine Hydrochloride
Mirtazapine
Venlafaxine Hydrochloride
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Peripheral Nervous System Agents
Serotonin and Noradrenaline Reuptake Inhibitors
Analgesics
Sensory System Agents