Major Depressive Disorder in outpatients
Conditions
Interventions
Product Name: Desvenlafaxine succinate SR tablets
Product Code: DVS-233
Pharmaceutical Form: Tablet
INN or Proposed INN: Desvenlafaxine succinate
CAS Number: 386750-22-7
Current Sponsor code: WY-45233
Sponsors
Wyeth Pharmaceuticals France, Wyeth Research Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatient men and women at least 18 years of age. 2. Except for women of non-child bearing potential, sexually active individuals participating in the study must agree to use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used double-barrier contraception, eg, condom plus diaphragm. It is important that subjects not become pregnant or impregnate others while they are in this study. 3. 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. If other allowable psychiatric diagnoses (see exclusion criterion 5) are present, MDD must be the predominant psychiatric disorder present. 4. Have depressive symptoms for at least 30 days before the screening visit. 5. Have a HAM-D17 total score =20 at the screening and baseline (study day –1) visits. 6. Have a score =2 on item 1 (depressed mood) of the HAM-D17 at the screening and baseline (study day –1) visits. 7. Have a score =4 on the Clinical Global Impressions Scale-Severity (CGI-S) at the screening and baseline (study day –1) visits. 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
Exclusion criteria: 1. Treatment with DVS SR at any time in the past. 2. Known hypersensitivity to venlafaxine (immediate release [IR] or extended release [ER]). 3. 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. 4. Women who are pregnant, breastfeeding, or plan to become pregnant during the study (for women of childbearing potential). A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. 5. a) 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 as assessed by the modified Mini International Neuropsychiatric Interview (MINI) and confirmed by the investigator. b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder as assessed by the modified MINI and considered by the investigator to be primary (causing a higher degree of distress or impairment than MDD); c) Presence (within 12 months before baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic) as assessed during the psychiatric evaluations. 6. A Covi Anxiety Scale total score greater than the Raskin Depression Scale total score at the screening or baseline (study day –1) visits. 7. A Covi Anxiety Scale score greater than 3 on any single item or a total score greater than 9 at the screening or baseline (study day –1) visits. 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 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. 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 before the screening visit. 15. Myocardial infarction within 180 days before the screening visit. 16. Clinically important abnormalities, as determined by the investigator, on screening physical examination, electrocardiogram (ECG), laboratory tests, or urine drug screen (UDS). The investigator and medical monitor will evaluate a positive UDS as to the potential impact and continued participation of the subject in the study. 17. Use of prohibited treatments. Refer to sections 13.1 and 13.2 and Table 13.1.1 (Prohibited Treatment, Permitted Treatment, and Table of Prohibited Treatments, respectively) for treatments and associated time frames.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo.;Secondary Objective: Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.;Primary end point(s): The primary efficacy variable will be the change from baseline on the HAM-D17 score at the final on therapy evaluation and will be tested by using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate. | — |
Countries
Estonia, Finland, Latvia, Lithuania
Outcome results
None listed