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Levomilnacipran in Healthy Males

NCT03249311 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-10-06

No results posted yet for this study

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.

Conditions

  • None (i.e. Healthy Volunteers)

Interventions

DRUG

Levomilnacipran

Escalating doses of 40 to 120mg/day every 7 days (+/- 1 day) throughout a 20-26 day period.

DRUG

Duloxetine

Escalating doses of 40 to 120mg/day every 7 days (+/- 1 day) throughout a 20-26 day period.

DRUG

Placebos

Escalating doses of 40 to 120mg/day every 7 days (+/- 1 day) throughout a 20-26 day period.

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • University of Ottawa

    lead OTHER

Principal Investigators

  • Pierre Blier, MD · The Royal's Institute of Mental Health Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-02
Primary Completion
2019-12-31
Completion
2022-05-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03249311 on ClinicalTrials.gov