A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study to Evaluate the Efficacy and Safety of 50 mg/day of DVS SR in Adult Outpatients With Major Depressive Disorder

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 850

Inclusion Criteria

Open-Label Phase, Screening/Baseline
1.Male or female subjects aged 18 years or older.
2.Outpatient status.
3.A primary diagnosis of MDD, single or recurrent episode, without psychotic features.
4.Depressive symptoms for at least 30 days before the screening visit.
5.A HAM-D17 total score =20 at the screening visit.
6.A score =2 on item 1 (depressed mood) of the HAM-D17 at the screening visit.
7.A score =4 on the Clinical Global Impressions Scale-Severity (CGI-S) at the screening visit.
Stability Phase
1.Response to treatment, as defined as a HAM-D17 total score of = 11 at the conclusion of the 8-week open-label phase.
2.A CGI-I score = 2 at the conclusion of the 8-week open-label phase.
Double-Blind Phase
1.Maintenance of stability, as defined as a HAM-D17 total score of = 11 at the conclusion of the 12-week stability phase
2.CGI-I score = 2 at the conclusion of the 12-week stability phase
3.Absence of an assessed HAM-D17 total score of = 16 or CGI-I score of = 4 at any visit during the stability phase..

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Open-Label Phase, Screening
1.Treatment with DVS SR at any time in the past.
2.Known or suspected allergy to venlafaxine.
3.Significant risk of suicide based on clinical judgment.
4.HAM-D17 score > 3 on Item 3 (Suicide) at the screening visit.
5.Columbia Suicide-Severity Rating Scale (C-SSRS) determination of yes” on question 4 or question 5 for the Suicidal Ideation section at the screening visit.
6.Pregnant or breastfeeding women.
7.a) Current psychoactive substance abuse or dependence, manic episode, posttraumatic stress disorder, obsessive compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current generalized anxiety disorder, panic disorder, or social anxiety disorder considered by the investigator to be primary; c) presence of a clinically important personality disorder.
8.Depression associated with the presence of an organic mental disorder due to a general medical condition or a neurologic disorder.
9.History of seizure disorder other than a single childhood febrile seizure.
10.Any major illness/condition.
11.History or current evidence of gastrointestinal disease 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.
12.History of neoplastic disorder (within 2 years), with the exception of basal cell or squamous cell carcinoma of the skin.
13.Known presence of raised intraocular pressure or history of narrow angle glaucoma.
14.Major acute illness within 90 days of the screening visit.
15.Myocardial infarction within 180 days of the screening visit.
Open-Label Phase, Baseline
1.Clinically important abnormalities indicated by electrocardiograms (ECG), vital signs, laboratory tests or urine drug screening.
2.HAM-D17 score >3 on Item 3 (Suicide) at the baseline visit.
3.Columbia Suicide-Severity Rating Scale (C-SSRS) determination of yes” on question 4 or question 5 for the Suicidal Ideation section at the baseline visit.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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Biogen Idec Research Limited

Updated 7/10/2015