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Levomilnacipran in Healthy Males

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ClinicalTrials.gov Identifier: NCT03249311
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Pierre Blier, University of Ottawa

Brief Summary:
Levomilnacipran is an antidepressant currently approved in Canada to treat Major Depressive Disorder (MDD). Thirty-six healthy male participants will receive escalating doses of levomilnacipran, duloxetine, or placebo every 7 days (+/- 1 day) throughout a 20 - 28 day period. After each dose escalation study participants will be asked to come to the clinic to conduct the necessary tests - these will include tyramine pressor tests as well as blood draws. The results of this study will allow the investigators to determine the dose(s) of levomilnacipran at which reuptake inhibition of norepinephrine and serotonin (chemicals utilized by nerve cells to transmit information to other cells) is achieved.

Condition or disease Intervention/treatment Phase
None (i.e. Healthy Volunteers) Drug: Levomilnacipran Drug: Duloxetine Drug: Placebos Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effectiveness of the Norepinephrine and Serotonin Reuptake Inhibitor Levomilnacipran in Healthy Males
Actual Study Start Date : March 2, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levomilnacipran
Participants will be randomly assigned to receive levomilnacipran, duloxetine, or placebo
Drug: Levomilnacipran
Escalating doses of 40 to 120mg/day every 7 days (+/- 1 day) throughout a 20-26 day period.
Other Name: Fetzima

Active Comparator: Duloxetine (Cymbalta)
Participants will be randomly assigned to receive levomilnacipran, duloxetine, or placebo
Drug: Duloxetine
Escalating doses of 40 to 120mg/day every 7 days (+/- 1 day) throughout a 20-26 day period.
Other Name: Cymbalta

Placebo Comparator: Levomilnacipran Placebo-matched capsules
Participants will be randomly assigned to receive levomilnacipran, duloxetine, or placebo
Drug: Placebos
Escalating doses of 40 to 120mg/day every 7 days (+/- 1 day) throughout a 20-26 day period.




Primary Outcome Measures :
  1. Primary End Point [ Time Frame: 24 months ]
    The degree of norepinephrine reuptake in response to the increasing levels of the study medication will be assessed and compared between three treatment groups.


Secondary Outcome Measures :
  1. Secondary End Points [ Time Frame: 24 months ]
    The degree of serotonin reuptake in response to the increasing levels of the study medication will be assessed and compared between three treatment groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male participants between 18 and 40 years-old
  • Written informed consent signed by the participant

Exclusion Criteria:

  • Lifetime personal history of diagnosis of major depressive disorder according to the DSM-V (American Psychiatric Association, 2013) using the Structured Clinical Interview for DSM-V Axis I Disorders, Research Version, Non-patient Edition (SCID-5-RV for DSM-V; First et al., 2015)
  • A history of suicidal ideation and behaviour, including self-harm and/or harm to others.
  • A history of substance abuse and/or dependence.
  • A positive drug screen for illicit drugs
  • Substantial alcohol use
  • Current use of Monoamine Oxidase Inhibitors (MAOIs), including the antibiotic linezolid and the thiazine dye methylthioninium chloride (methylene blue)
  • Current use of serotonin-precursors (such as L-tryptophan, oxitriptan)
  • Current use of serotonergic drugs (triptans, certain tricyclic antidepressants, lithium, tramadol, St. John's Wort)
  • Concomitant use of NSAIDS, ASA, and other anticoagulants.
  • Current use of Thioridazine
  • Current use of CYP1A2 Inhibitors
  • Current use of Triptans (5HT1 Agonists)
  • Blood pressure greater than 140/90 and/or a pulse rate greater than 90 bpm
  • Recent history of myocardial infarction, cerebrovascular accident, cardiac arrhythmias, or unstable heart disease.
  • Evidence of significant physical illness contraindicating the use of levomilnacipran and duloxetine found on the physical exam or in the laboratory data obtained during the first week of the study
  • Current use of medication that may affect voiding (ie- anticholinergics)
  • History of obstructive urinary disorders and dysuria, prostatic hypertrophy, prostatitis, and other lower urinary tract obstructive disorders.
  • History of Stevens-Johnson Syndrome and Erythema multiforme.
  • Diabetes Type I and II
  • Fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency.
  • Hepatic Impairment
  • Uncontrolled narrow-angle glaucoma
  • Severe renal impairment
  • History of seizure disorder
  • Anatomically narrow ocular angles.
  • Osteoporosis or major risk for bone fractures.

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): NCT03249311


Contacts
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Contact: Ubah Mohamed, RPN 613-722-6521 ext 7828 ubah.mohamed@theroyal.ca
Contact: Liz Kamler, RN 613-722-6521 ext 6405 liz.kamler@theroyal.ca

Locations
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Canada, Ontario
Institute of Mental Health Research, Royal Ottawa Mental Health Centre Recruiting
Ottawa, Ontario, Canada, K1Z 7K4
Contact: Ubah Mohamed, RPN    613-722-6521 ext 7228    ubah.mohamed@theroyal.ca   
Contact: Liz Kamler, RN    613-722-6521 ext 6405    liz.kamler@theroyal.ca   
Principal Investigator: Pierre Blier, MD         
Sponsors and Collaborators
University of Ottawa
Allergan
Investigators
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Principal Investigator: Pierre Blier, MD The Royal's Institute of Mental Health Research

Publications:
Blier, P., Aldosary, F., Tremblay, P., & Hébert, C. (2010). Inhibition of norepinephrine and serotonin reuptake by venlafaxine, paroxetine and atomoxetine in depressed patients. Int J Neuropsychopharmacol 13(Suppl 1):143S.
First, M.B., Williams, J.B.W., Karg, R.S., & Spitzer, R.L. (2015). Structured clinical interview for DSM-5-research version. Arlington: American Psychiatric Association.

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Responsible Party: Pierre Blier, Endowed Research Chair and Director of Mood Disorders Research Unit, University of Ottawa
ClinicalTrials.gov Identifier: NCT03249311    
Other Study ID Numbers: REB2017004
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pierre Blier, University of Ottawa:
Levomilnacipran
Antidepressant
Ottawa
Selective Norepinephrine Reuptake Inhibitor
Healthy males
Tyramine response
Serotonin
Norepinephrine
Additional relevant MeSH terms:
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Norepinephrine
Duloxetine Hydrochloride
Milnacipran
Levomilnacipran
Serotonin
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Sympathomimetics
Autonomic Agents
Vasoconstrictor Agents
Serotonin Receptor Agonists
Serotonin Agents
Analgesics, Non-Narcotic