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

NCT00619619 | Completed Phase 2 Results

• 3 other identifiers: 3151A6-2000B20610123151A6-2000-US
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 9

Brief 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. This study will also characterize the pharmacokinetic profile of DVS SR in children and adolescents with major depressive disorder.

Conditions

Depression; Major Depressive Disorder

Keywords

MDD; Child; Adolescent; Pharmacokinetic; Outpatient; Pediatrics; Depressive Disorder; Major

Outcome Measures

Primary Outcomes (5)

• 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.

  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).

  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).

  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).

  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).

  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

  Day 1, Day 28, and Day 56

• Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method

  Day 1, Day 28, and Day 56

Other Outcomes (4)

• Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score

  Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)

• Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score

  Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)

• Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit

  Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)

Study Arms (1)

A

EXPERIMENTAL

Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)

Interventions

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.

A

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (9)

Pfizer Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Pfizer Investigational Site

North Miami, Florida, 33161, United States

Location

Pfizer Investigational Site

Terre Haute, Indiana, 47802, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67211, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70114, United States

Location

Pfizer Investigational Site

New York, New York, 10032, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44106-5080, United States

Location

Pfizer Investigational Site

Hershey, Pennsylvania, 17033, United States

Location

Pfizer Investigational Site

Houston, Texas, 77008, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Depressive Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 23, 2011
• Results First Posted: February 21, 2011

Record last verified: 2011-02

Locations

US (9)