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

• Register: EUCTR
• Last refreshed on: 12 June 2012
• Main ID: EUCTR2008-005424-85-LV
• Date of registration: 03/06/2009
• Prospective Registration: Yes
• Primary sponsor: Wyeth Pharmaceuticals, Inc.,Acting through its division Wyeth Research, a Pfizer Company
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 19/06/2009
• Target sample size: 850
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005424-85
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Estonia, Finland, France, Latvia, Lithuania, Slovakia

Key inclusion & exclusion criteria

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

The desvenlafaxine succinate sustained release formulation, DVS SR, is being used in development programs for the treatment of major depressive disorder (MDD).

Intervention(s)

Product Name: DVS SR 50mg
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: Desvenlafaxine
CAS Number: 386750-22-7
Current Sponsor code: WY-45233, WY-45233-1
Other descriptive name: DVS-233
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: DVS SR 25mg
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: Desvenlafaxine
CAS Number: 386750-22-7
Current Sponsor code: WY-45233, WY-45233-1
Other descriptive name: DVS-233
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: The primary objective is to compare the long-term efficacy and safety of treatment with DVS SR 50 mg/day versus placebo in MDD subjects stabilized on DVS SR, using a randomized withdrawal design. This comparison will be based on time to relapse between DVS SR and placebo treatment groups.

Primary end point(s): The primary endpoint is the time to relapse following randomization to the double-blind phase. Relapse is defined as the occurrence of one or more of the following at any time during the double-blind phase:
• HAM-D17 total score of = 16 at any visit
• discontinuation for unsatisfactory efficacy response
• hospitalization for depression
• attempted or completed suicide

Secondary Objective: The secondary objective is to assess the long-term response of subjects receiving 50 mg/day of DVS SR versus placebo through clinical global assessments, remission (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] = 7) and functional and quality of life outcomes.

Secondary ID(s)

2008-005424-85-FI

3151A1-3360-WW