Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD

Depressive Disorder, Major Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Paroxetine-referenced, Parallel-group Study to Evaluate the Safety, Efficacy, and Tolerability of 3 Fixed Doses (50mg, 100mg, AND 200mg) of Desvenlafaxine Succinate Sustained-release Tablets in Adult Outpatients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445679
• Other study ID #: 3151A1-336
• Status: Completed
• Phase: Phase 3
• First received: March 6, 2007
• Last updated: October 8, 2013
• Start date: July 2007
• Est. completion date: February 2009

Study information

• Verified date: October 2013
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of HealthIndia: Ministry of HealthKorea: Food and Drug AdministrationTaiwan: Department of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.

Description:

The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 807
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Primary Inclusion Criteria:

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

2. Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features.

3. Have a HAM D17 total score =20 at the screening and baseline (study day 1) visit.

Primary Exclusion Criteria:

1. Treatment with DVS SR at any time in the past.

2. 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.

3. 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.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• DVS SR
Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper
• Paroxetine
20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

China,  India,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)	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.	8 weeks	No
Secondary	Clinical Global Impressions Scale-Improvement (CGI-I) Scores	CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).	8 weeks	No
Secondary	Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores	CGI-S is a global rating scale that measures the severity of a subject's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).	8 weeks	No
Secondary	Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline	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 8 weeks	No
Secondary	Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline	The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject's assessment of an improvement in pain.	8 weeks	No
Secondary	Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline	HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 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). Total score ranges from 0 to 22; higher score indicates more depression.	8 weeks	No
Secondary	Covi Anxiety Scale Score Mean Change From Baseline	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, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.	8 weeks	No