DepressionPhase 2NCT00619619

Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder

A Phase 2 study testing Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) in people with Depression and Major Depressive Disorder, run by Wyeth is now a wholly owned subsidiary of Pfizer at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this study is to test the safety and tolerability of single ascending doses of Desvenlafaxine Succinate Sustained-Release (DVS SR) in both child and adolescent outpatients with major depressive disorder. Read more about this study

Who is it for?: Ages 7 to 17 years
Conditions the study is for: Depression, Major Depressive Disorder
What is being tested?: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 9 sitesUnited States
Study dates: Feb 2008to Nov 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 7 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female outpatient between 7 and 17 years of age at baseline who meet Diagnostic and Statistic Manual of Mental Disorders, Fourth Edition, Text Revision criteria for major depressive disorder.
Children's Depression Rating Scale --Revised (CDRS-R) score greater than 40 at the screening and study day -1 (baseline) visits and Clinical Global Impressions Scale--Severity (CGI-S) score of greater than or equal to 4 at the screening and study day -1 (baseline) visits.
Depression of at least moderate severity with symptoms for at least 1 month before screening and that could, in the investigator's opinion, respond to therapy with antidepressant(s) alone (without concomitant psychotherapy).
Other inclusion criteria apply.

Who cannot join

History or current evidence of a medical condition known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs; history or presence of any other medical condition that might confound the study or put the study participant at greater risk during participation; known hypersensitivity to venlafaxine.
History of suicide attempt or gesture in which the intent was suicide or serious self-harm or acute suicidality to such a degree that precaution against suicide must be exercised.
Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a diagnosis of bipolar disorder or psychotic disorder or current (within 12 months before baseline) generalized anxiety disorder, panic disorder, social anxiety disorder, or attention deficit hyperactivity disorder (ADHD) if considered by the investigator to be primary (causing a higher degree of distress or impairment than MDD) or presence (within 12 months before baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, or narcissistic) as assessed during the psychiatric evaluations or history or presence of MDD with psychotic features.
Other exclusion criteria apply.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Pfizer Investigational Site
Cleveland, Ohio, 44106-5080
Pfizer Investigational Site
Hershey, Pennsylvania, 17033
Pfizer Investigational Site
Houston, Texas, 77008
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
New Orleans, Louisiana, 70114
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
North Miami, Florida, 33161
Pfizer Investigational Site
Terre Haute, Indiana, 47802
Pfizer Investigational Site
Wichita, Kansas, 67211

Other trials in United States

About this study

Official title: Final Report: Multicenter, Open-Label, Safety, Tolerability, And Pharmacokinetic Study To Evaluate Single Ascending Doses And Subsequent Short-Term Administration Of Fixed Doses Of DVS SR Tablets In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder

Conditions: Depression, Major Depressive Disorder
Being tested: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
Keywords: MDD, Child, Adolescent, Pharmacokinetic, Outpatient, Pediatrics, Depressive Disorder, Major
Medical subject headings: Depression, Depressive Disorder, Major, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)Drug
DVS SR Tablets of 10mg, 25mg, 50mg, and 100mg. Assigned DVS SR daily doses of 10mg, 25mg, 50mg, 100mg, or 200mg for up to 8 weeks.

Study groups in NCT00619619
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)
AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect.
Measured: Baseline to Follow-up (up to Day 77)
Maximum Observed Plasma Concentration (Cmax)
Noncompartmental pharmacokinetic (PK) parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms per milliliter (ng/mL).
Measured: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).
Measured: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).
Measured: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
Area Under the Curve From Time Zero to Infinity (AUC0-∞)
AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to infinity. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).
Measured: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56

Secondary outcomes (2)

Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method
Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A*W^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose [(ng*hr/mL)/mg of dose].
Measured: Day 1, Day 28, and Day 56
Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method
Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A*W^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose [(ng*hr/mL)/mg of dose].
Measured: Day 1, Day 28, and Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Nov 2009

First posted21 Feb 2008 (estimated)
Study startFeb 2008
Primary completionNov 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies 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 2
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00619619
Sponsor's protocol ID: 3151A6-2000
Other IDs: B2061012, 3151A6-2000-US
Status last verified: Feb 2011
First submitted: 28 Jan 2008
Last updated: 23 Feb 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Final Report: Multicenter, Open-Label, Safety, Tolerability, And Pharmacokinetic Study To Evaluate Single Ascending Doses And Subsequent Short-Term Administration Of Fixed Doses Of DVS SR Tablets In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT00619619
Acronym / sponsor ID: 3151A6-2000
Conditions: Depression, Major Depressive Disorder
Keywords: MDD, Child, Adolescent, Pharmacokinetic, Outpatient, Pediatrics, Depressive Disorder, Major
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 21 Feb 2008 (estimated)
Results: Posted 21 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
A	Experimental	Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)

Who may qualify

Ages: 7 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Male or female outpatient between 7 and 17 years of age at baseline who meet Diagnostic and Statistic Manual of Mental Disorders, Fourth Edition, Text Revision criteria for major depressive disorder.
Children's Depression Rating Scale --Revised (CDRS-R) score greater than 40 at the screening and study day -1 (baseline) visits and Clinical Global Impressions Scale--Severity (CGI-S) score of greater than or equal to 4 at the screening and study day -1 (baseline) visits.
Depression of at least moderate severity with symptoms for at least 1 month before screening and that could, in the investigator's opinion, respond to therapy with antidepressant(s) alone (without concomitant psychotherapy).
Other inclusion criteria apply.

Key exclusion criteria (4 listed)

History or current evidence of a medical condition known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs; history or presence of any other medical condition that might confound the study or put the study participant at greater risk during participation; known hypersensitivity to venlafaxine.
History of suicide attempt or gesture in which the intent was suicide or serious self-harm or acute suicidality to such a degree that precaution against suicide must be exercised.
Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a diagnosis of bipolar disorder or psychotic disorder or current (within 12 months before baseline) generalized anxiety disorder, panic disorder, social anxiety disorder, or attention deficit hyperactivity disorder (ADHD) if considered by the investigator to be primary (causing a higher degree of distress or impairment than MDD) or presence (within 12 months before baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, or narcissistic) as assessed during the psychiatric evaluations or history or presence of MDD with psychotic features.
Other exclusion criteria apply.

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 Succinate Sustained-Release Tablets (DVS SR)DVS SR Tablets of 10mg, 25mg, 50mg, and 100mg. Assigned DVS SR daily doses of 10mg, 25mg, 50mg, 100mg, or 200mg for up to 8 weeks.	Drug	A

Primary outcome

Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline to Follow-up (up to Day 77)
AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect.
Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
Noncompartmental pharmacokinetic (PK) parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms per milliliter (ng/mL).
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).
Plasma Decay Half-Life (t1/2)
Time frame: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).
Area Under the Curve From Time Zero to Infinity (AUC0-∞)
Time frame: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to infinity. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).

2 secondary outcomes

Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method
Time frame: Day 1, Day 28, and Day 56
Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method
Time frame: Day 1, Day 28, and Day 56

Results and safety

Results posted to the registry on 21 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Desvenlafaxine 10 mg Children	6	6
Desvenlafaxine 25 mg Children	7	7
Desvenlafaxine 50 mg Children	9	8
Desvenlafaxine 100 mg Children	7	6
Desvenlafaxine 25 mg Adolescent	7	5
Desvenlafaxine 50 mg Adolescent	7	7
Desvenlafaxine 100 mg Adolescent	8	7
Desvenlafaxine 200 mg Adolescent	8	5

Primary outcome: Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)

Time frame: Baseline to Follow-up (up to Day 77). Number. Unit: participants

Measure	Desvenlafaxine 10 mg Children n = 6	Desvenlafaxine 25 mg Children n = 7	Desvenlafaxine 50 mg Children n = 9	Desvenlafaxine 100 mg Children n = 7	Desvenlafaxine 25 mg Adolescent n = 7	Desvenlafaxine 50 mg Adolescent n = 7	Desvenlafaxine 100 mg Adolescent n = 8	Desvenlafaxine 200 mg Adolescent n = 8
Serious Adverse Events	0	0	0	0	1	0	0	0
Non-serious Adverse Events	1	3	3	7	4	2	7	8

Population analysed: Safety population includes all treatment-assigned participants who have taken at least 1 dose of study treatment.

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56. Mean (Standard Deviation). Unit: ng/mL

Measure	Desvenlafaxine 10 mg Children n = 6	Desvenlafaxine 25 mg Children n = 7	Desvenlafaxine 50 mg Children n = 9	Desvenlafaxine 100 mg Children n = 7	Desvenlafaxine 25 mg Adolescent n = 7	Desvenlafaxine 50 mg Adolescent n = 7	Desvenlafaxine 100 mg Adolescent n = 8	Desvenlafaxine 200 mg Adolescent n = 8
Value	33.9 (12.1)	98 (60.5)	108 (27)	263 (66)	46.1 (15.9)	93.9 (15.5)	202 (92)	449 (126)

Population analysed: PK population: all participants in the Safety population with available plasma concentration data from both the inpatient and outpatient phases of the study that are properly identified with respect to dosing and sampling times.

Primary outcome: Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56. Mean (Standard Deviation). Unit: hr

Measure	Desvenlafaxine 10 mg Children n = 6	Desvenlafaxine 25 mg Children n = 7	Desvenlafaxine 50 mg Children n = 9	Desvenlafaxine 100 mg Children n = 7	Desvenlafaxine 25 mg Adolescent n = 7	Desvenlafaxine 50 mg Adolescent n = 7	Desvenlafaxine 100 mg Adolescent n = 8	Desvenlafaxine 200 mg Adolescent n = 8
Value	4.7 (2.1)	4.3 (1.4)	5.1 (3)	5.0 (2.0)	4.3 (0.7)	8.7 (7.1)	7.6 (3.4)	7.5 (4.1)

Population analysed: PK population

Primary outcome: Plasma Decay Half-Life (t1/2)

Time frame: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56. Mean (Standard Deviation). Unit: hr

Measure	Desvenlafaxine 10 mg Children n = 6	Desvenlafaxine 25 mg Children n = 7	Desvenlafaxine 50 mg Children n = 9	Desvenlafaxine 100 mg Children n = 7	Desvenlafaxine 25 mg Adolescent n = 7	Desvenlafaxine 50 mg Adolescent n = 7	Desvenlafaxine 100 mg Adolescent n = 8	Desvenlafaxine 200 mg Adolescent n = 8
Value	7.8 (1.4)	8.6 (1.6)	9.4 (2.7)	9.0 (2.0)	12 (3)	10.2 (3.7)	9.6 (2.0)	9.8 (2.7)

Population analysed: PK population

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Desvenlafaxine 10 mg Children	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Desvenlafaxine 25 mg Children	0 of 7 (0%)	3 of 7 (42.9%)	Not reported
Desvenlafaxine 50 mg Children	0 of 9 (0%)	3 of 9 (33.3%)	Not reported
Desvenlafaxine 100 mg Children	0 of 7 (0%)	7 of 7 (100%)	Not reported
Desvenlafaxine 25 mg Adolescent	1 of 7 (14.3%)	4 of 7 (57.1%)	Not reported
Desvenlafaxine 50 mg Adolescent	0 of 7 (0%)	2 of 7 (28.6%)	Not reported
Desvenlafaxine 100 mg Adolescent	0 of 8 (0%)	7 of 8 (87.5%)	Not reported
Desvenlafaxine 200 mg Adolescent	0 of 8 (0%)	8 of 8 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link 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.

Pfizer CT.gov Call Center study director

Pfizer

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 4 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: finished, as of the sponsor's last update on 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs) (time frame: Baseline to Follow-up (up to Day 77)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00619619.

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 23 Feb 2011.