Levomilnacipran in Healthy Males

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Ottawa
• Collaborator: Allergan
• Treatments: Duloxetine Hydrochloride; Levomilnacipran; Milnacipran; Norepinephrine; Serotonin; Serotonin Uptake Inhibitors

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.