Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder

Depressive Disorder, Major Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Duloxetine-Referenced, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50mg, 100mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384033
• Other study ID #: 3151A1-335
• Status: Completed
• Phase: Phase 3
• First received: October 2, 2006
• Last updated: February 9, 2012
• Start date: September 2006
• Est. completion date: September 2007

Study information

• Verified date: February 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 638
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.

• Depressive symptoms for at least 30 days before the screening visit.

• Outpatient men and women at least 18 years of age.

Exclusion Criteria:

• Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.

• Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.

• Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Desvenlafaxine Succinate Sustained-Release (DVS SR)
50 mg tablet, once daily dosing for 8 weeks
• Desvenlafaxine Succinate Sustained-Release (DVS SR)
100 mg tablet, once daily dosing for 8 weeks
• Placebo
Matching placebo tablets and capsules, once daily dosing for 8 weeks
• Duloxetine 60 mg/day
60 mg capsule, once daily dosing for 8 weeks

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Beverly Hills	California
United States	Pfizer Investigational Site	Brown Deer	Wisconsin
United States	Pfizer Investigational Site	Burbank	California
United States	Pfizer Investigational Site	Clementon	New Jersey
United States	Pfizer Investigational Site	Dayton	Ohio
United States	Pfizer Investigational Site	Edwardsville	Illinois
United States	Pfizer Investigational Site	Encino	California
United States	Pfizer Investigational Site	Farmington Hills	Michigan
United States	Pfizer Investigational Site	Flint	Michigan
United States	Pfizer Investigational Site	Los Alamitos	California
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Northridge	California
United States	Pfizer Investigational Site	Okemos	Michigan
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Pasadena	California
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	South Miami	Florida
United States	Pfizer Investigational Site	St. Petersburg	Florida
United States	Pfizer Investigational Site	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation	HAM-D17: 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.	Baseline and Week 8 or FOT
Secondary	Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation	CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale relative to the baseline assessment. Higher score = more affected.	Week 8 or FOT
Secondary	Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation	CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.	Baseline and Week 8 or FOT
Secondary	Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation	MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).	Baseline and Week 8 or FOT
Secondary	Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation	Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help.	Baseline and Week 8 or FOT
Secondary	Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation	HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe).	Baseline and Week 8 or FOT
Secondary	Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation	HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe).	Baseline and Week 8 or FOT
Secondary	Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation	COVI anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, to 5 = Very much. Worst value is 15 and best value is 3.	Baseline and Week 8 or FOT
Secondary	Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation	VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI.	Baseline and Week 8 or FOT

External Links

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