Effectiveness of the Dual Serotonin Norepinephrine Reuptake Inhibitor Desvenlafaxine Succinate in Healthy Volunteers (DVS)

August 4, 2011 updated by: University of Ottawa

Effectiveness of the Dual Serotonin Norepinephrine Reuptake Inhibitor Desvenlafaxine Succinate in Healthy Females and Males

DVS is the main metabolite of the antidepressant/anxiolytic medication Venlafaxine (Effexor). Like parent compound, DVS is an antidepressant inhibiting both serotonin (5-HT) and norepinephrine (NE) reuptake. However, no studies to date describe the in vivo potency of this drug on monoamines reuptake. Consequently, it appears essential to determine the potency of DVS in human subjects using a wide dose range in order to determine at which dose(s) it starts inhibiting 5-HT and NE reuptake. The investigators are interested in learning whether there is a gender difference in the dose of the study medication at which NE reuptake inhibition occurs.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Z 7K4
        • Recruiting
        • University of Ottawa Institute of Mental Health Research
        • Contact:
        • Principal Investigator:
          • Pierre Blier, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female subjects between 18 and 40 years of age, including those on oral contraceptive pills
  • Male subjects between 18-40 years of age
  • Written informed consent signed by the subject.

Exclusion Criteria:

  • Life-time personal history of diagnosis of major depression according to the DSM-IV (American Psychiatry Association, 1994) using the MINI (Sheehan et al. 1998)
  • Blood pressure greater than 140/90 and a pulse rate greater than 90bpm
  • Evidence of significant physical illness contraindicating the use of DVS, found on physical or in the laboratory data obtained during the first week of the study
  • Obvious mental retardation rendering the response to investigators unreliable
  • Pregnancy, or absence of adequate contraceptive method.
  • Concurrent use of psychotropic medication such as antipsychotics, mood stabilizers or regular use of benzodiazepines.
  • Participation in a clinical trial within 30 days of entry into the current study
  • Intolerance to Desvenlafaxine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Female
Drug: Desvenlafaxine succinate

Tablets of 50 mg,100 mg; Dosing regimen: 50, 100, 200 mg/day; 1 week for each dose regimen;

1 tablet a day for doses of 50 and 100mg/day, and 2 tablets of 100mg for dose of 200mg/day

Other Names:
  • Pristiq
Experimental: Male
Drug: Desvenlafaxine succinate

Tablets of 50 mg,100 mg; Dosing regimen: 50, 100, 200 mg/day; 1 week for each dose regimen;

1 tablet a day for doses of 50 and 100mg/day, and 2 tablets of 100mg for dose of 200mg/day

Other Names:
  • Pristiq

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The degree of norepinephrine reuptake in response to the increasing levels of the study medication will be assessed and compared between genders
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
The degree of serotonin reuptake in response to the increasing levels of the study medication will be assessed and compared between genders
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ottawa

Investigators

  • Principal Investigator: Pierre Blier, M.D., Ph.D., University of Ottawa Institute of Mental Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (Estimate)

April 9, 2010

Study Record Updates

Last Update Posted (Estimate)

August 8, 2011

Last Update Submitted That Met QC Criteria

August 4, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB-2009036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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