Status:
UNKNOWN
Levomilnacipran in Healthy Males
Lead Sponsor:
University of Ottawa
Collaborating Sponsors:
Allergan
Conditions:
None (i.e. Healthy Volunteers)
Eligibility:
MALE
18-40 years
Phase:
PHASE4
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, dulox...
Detailed Description
Levomilnacipran (Fetzima) is the active enantiomer of milnacipran (Ixel, Savella) for norepinephrine (NE) and serotonin (5-hydroxytryptamine, 5-HT) reuptake. It has an approximate eight-fold greater a...
Eligibility Criteria
Inclusion
- Male participants between 18 and 40 years-old
- Written informed consent signed by the participant
Exclusion
- 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.
Key Trial Info
Start Date :
March 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03249311
Start Date
March 2 2018
End Date
May 1 2022
Last Update
October 6 2021
Active Locations (1)
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1
Institute of Mental Health Research, Royal Ottawa Mental Health Centre
Ottawa, Ontario, Canada, K1Z 7K4