Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)

NCT00831415 | Completed Phase 3 Results

• 2 other identifiers: 3151A1-3350B2061002
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 17

Brief Summary

The primary objective of this study is to evaluate the long-term safety of desvenlafaxine succinate sustained release tablets during 10-month open-label treatment of Japanese subjects with major depressive disorder (MDD). The secondary objective is to evaluate the long-term response of subjects receiving desvenlafaxine succinate sustained release tablets by clinical global evaluation, general well-being and absence of symptoms.

Conditions

Major Depressive Disorder

Keywords

Open-label Long-term extension study

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score

  HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4) with 0=none/absent and 4=most severe, for a maximum total score of 50. Higher scores indicate greater severity. FOT evaluation is defined as the last "on-therapy" evaluation, regardless of the number of days on therapy. Analysis on Observed cases (non-missing data) and Last observation carried forward (LOCF); LOCF method of imputation for any missing value at any visit.

  Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation

• Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

  Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be an SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.

  Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment

Secondary Outcomes (2)

• Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)

  Day 308 or FOT Evaluation

• Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score

  Baseline (Extension Study) up to Day 308 or FOT Evaluation

Study Arms (1)

1

EXPERIMENTAL

DVS SR

Drug: desvenlafaxine succinate sustained release tablets

Interventions

desvenlafaxine succinate sustained release tablets DRUG

25-mg or 50-mg DVS SR tablets taken orally, once daily, at the same time each day. 100 mg dose will be supplied as 2 tablets of 50-mg tablet.

Also known as: DVS-233; Pristiq

1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients who have completed double-blind therapy in short-term study for the indication of major depressive disorder (MDD), including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study.

You may not qualify if:

• Clinically important abnormalities on baseline (day 56 of the short-term study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before day 56 in the previous short-term study for the indication of MDD.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (17)

Pfizer Investigational Site

Aichi, Japan

Location

Pfizer Investigational Site

Chiba, Japan

Location

Pfizer Investigational Site

Fukuoka, Japan

Location

Pfizer Investigational Site

Fukushima, Japan

Location

Pfizer Investigational Site

Gunma, Japan

Location

Pfizer Investigational Site

Hiroshima, Japan

Location

Pfizer Investigational Site

Hokkaido, Japan

Location

Pfizer Investigational Site

Hyōgo, Japan

Location

Pfizer Investigational Site

Ishikawa, Japan

Location

Pfizer Investigational Site

Kanagawa, Japan

Location

Pfizer Investigational Site

Kumamoto, Japan

Location

Pfizer Investigational Site

Kyoto, Japan

Location

Pfizer Investigational Site

Osaka, Japan

Location

Pfizer Investigational Site

Saga, Japan

Location

Pfizer Investigational Site

Saitama, Japan

Location

Pfizer Investigational Site

Shiga, Japan

Location

Pfizer Investigational Site

Tokyo, Japan

Location

Related Links

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

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids

Results Point of Contact

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

ClinicalTrials.govCallCenter@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 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 29, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 7, 2018
• Results First Posted: January 30, 2012

Record last verified: 2018-11

Locations

JP (17)