Clinical trial NCT00445679: Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Keywords: major depressive disorder
MDD
depression
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-09
Enrollment: 807
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)
timeFrame: 8 weeks
Secondary outcomes:
measure: Clinical Global Impressions Scale-Improvement (CGI-I) Scores
timeFrame: 8 weeks
measure: Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores
timeFrame: 8 weeks
measure: Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline
timeFrame: Baseline and 8 weeks
measure: Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline
timeFrame: 8 weeks
measure: Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline
timeFrame: 8 weeks
measure: Covi Anxiety Scale Score Mean Change From Baseline
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Guangdong Province
country: China
city: Hunan Province
country: China
city: Jiangsu Province
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanxi Province
country: China
city: Sichuan Province
country: China
city: Yunnan Province
country: China
city: Zhejiang Province
country: China
city: Andhra Pradesh
country: India
city: Andhra Pradesh
country: India
city: Andhra Pradesh
country: India
city: Andhra Pradesh
country: India
city: Chandigarh
country: India
city: Gujarat
country: India
city: Gujarat
country: India
city: Karnataka
country: India
city: Karnataka
country: India
city: Maharashtra
country: India
city: Maharashtra
country: India
city: Maharashtra
country: India
city: Mumbai Maharashtra
country: India
city: New Delhi
country: India
city: Punjab
country: India
city: Uttar Pradesh
country: India
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Chang-Hua
country: Taiwan
city: KaoHsiung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For China: medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: