HealthyPhase 1DVSNCT01101152
Effectiveness of the Dual Serotonin Norepinephrine Reuptake Inhibitor Desvenlafaxine Succinate in Healthy Volunteers
A Phase 1 study testing Desvenlafaxine succinate in people with Healthy, run by University of Ottawa at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Desvenlafaxine succinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Institute of Mental Health Research
Ottawa, Ontario, K1Z 7K4
Olga Chernoloz, B.Sc.Pharm, 613-722-6521 ext. 6405, olga.chernoloz@rohcg.on.ca
Pierre Blier, M.D., Ph.D.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Desvenlafaxine succinate
- Keywords
- Antidepressant, healthy volunteers, desvenlafaxine succinate, norepinephrine reuptake, serotonin reuptake, tyramine test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desvenlafaxine succinateDrug
Also called Pristiq
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
| Study group | Role | What they receive |
|---|---|---|
| Female | Experimental | Not described Receives: Drug: Desvenlafaxine succinate |
| Male | Experimental | Not described Receives: Drug: Desvenlafaxine succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of norepinephrine reuptake in response to the increasing levels of the study medication will be assessed and compared between genders
Measured: 1 month
Secondary outcomes (1)
The degree of serotonin reuptake in response to the increasing levels of the study medication will be assessed and compared between genders
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Investigators
- Pierre Blier, M.D., Ph.D., Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101152
- Sponsor's protocol ID
- REB-2009036
- Acronym
- DVS
- Status last verified
- Apr 2010
- First submitted
- 8 Apr 2010
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Dual Serotonin Norepinephrine Reuptake Inhibitor Desvenlafaxine Succinate in Healthy Females and Males
- ClinicalTrials.gov ID
- NCT01101152
- Acronym / sponsor ID
- DVS / REB-2009036
- Conditions
- Healthy
- Keywords
- Antidepressant, healthy volunteers, desvenlafaxine succinate, norepinephrine reuptake, serotonin reuptake, tyramine test
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female | Experimental | Drug: Desvenlafaxine succinate |
| Male | Experimental | Drug: Desvenlafaxine succinate |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desvenlafaxine succinateAlso: PristiqTablets 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 | Drug | Female, Male |
Primary outcome
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 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
- University of Ottawa Institute of Mental Health Research homepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Blier, M.D., Ph.D. principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Desvenlafaxine succinate in people with Healthy, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga Chernoloz, B.Sc.Pharm (613-722-6521 ext. 6405, olga.chernoloz@rohcg.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2011.