The primary objective of this study is to compare the antidepressant efficacy and safety of DVS-233 SR with those of placebo in adult outpatients with major depressive disorder (MDD).

Condition	Treatment or Intervention	Phase
Major Depressive Disorder	Drug: DVS-233 SR  Drug: Venlafaxine ER	Phase III

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Outpatients.
• Men and women 18 to 75 years of age, inclusive.
• Women of child-bearing potential must have a negative serum pregnancy test at screening and use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used double-barrier contraception, e.g. condom plus diaphragm.
• Subjects must have a primary diagnosis of major depressive disorder (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 are present, MDD must be the predominant psychiatric disorder present. (See exclusion Criterion 6 for other psychiatric diagnoses that are not allowable.)
• Depressive symptoms for at least 30 days before the screening visit.
• Minimum screening and study day –1 (baseline) scores of 22 on the Hamilton Psychiatric Rating Scale for Depression (HAM D17).
• Minimum screening and study day –1 (baseline) scores of 2 on item 1 (depressed mood) of the Hamilton Psychiatric Rating Scale for Depression (HAM-D17).
• Minimum screening and study day –1 (baseline) scores of 4 on Clinical Global Impressions-Severity scale (CGI-S).
• Signed and dated informed consent before any screening procedures.

Exclusion Criteria:

• Treatment with DVS-233 SR at any time in the past.
• Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day 1.
• Known hypersensitivity to venlafaxine (IR or ER).
• Significant risk of suicide based on clinical judgment. Common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
• Current (within 12 months of 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). Current (within 12 months of 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. Presence (within 12 months of baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic).
• Additional exclusion criteria to be outlined at screening visit.

Belgium
      Centre Hospitalier de la Citadelle, Liège,  4000,  Belgium; Recruiting
      Clinique Notre Dame, Tournay,  B-7500,  Belgium; Recruiting
      Cliniques Universitaires (UCL) de Mont-Godinne, Yvoir,  B-5530,  Belgium; Recruiting
Croatia
      Klinicka bolnica Osijek, Osijek,  31000,  Croatia; Recruiting
      Klinicka bolnica Split, Split,  21000,  Croatia; Recruiting
      Klinicki bolnicki centar Rijeka, Rijeka,  51000,  Croatia; Recruiting
      Psihijatrijska bolnica Vrapce, Zagreb,  10090,  Croatia; Recruiting
Estonia
      Mustamäe Health Care Center, Tallinn,  12618,  Estonia; Recruiting
      Viljandi Hospital Foundation Psychiatric Clinic, Viljandi,  71024,  Estonia; Recruiting
      Jaanson & Lääne Outpatient Clinic, Tartu,  51008,  Estonia; Recruiting
France
      Centre Hospitalier Saint-Anne, Paris,  75014,  France; Recruiting
      Research Site, Rennes,  35000,  France; Recruiting
      Research Site, Joue-les-Tours,  37300,  France; Recruiting
      Immeuble Impérial, La Valette-du-Var,  83160,  France; Recruiting
      Research Site, Tours,  37000,  France; Recruiting
      Research Site, Caen,  14000,  France; Recruiting
      Immeuble Le Sully, Marseille,  13012,  France; Recruiting
      Résidence Saint-Michel, Douai,  59500,  France; Recruiting
Germany
      Praxis für Psychiatrie, Berlin,  13053,  Germany; Recruiting
      Praxis für Psychiatrie, Berlin,  13156,  Germany; Recruiting
      Klinik und Poliklinik für Psychiatrie, Göttingen,  D- 37075,  Germany; Recruiting
      Praxis für Psychiatrie, Hildesheim,  31134,  Germany; Recruiting
      Emovis GmbH, Berlin,  10629,  Germany; Recruiting
Latvia
      Liepaja Psychoneurological Hospital, Liepaja,  LV-3401,  Latvia; Recruiting
      Psychoneurological hospital of Jelgava, Jelgava,  LV-3008,  Latvia; Recruiting
      Riga Mental Health Care Center, Riga,  LV-1005,  Latvia; Recruiting
      Psychoneurological Hospital of Strenci, Strenci,  4730,  Latvia; Recruiting
Lithuania
      Vilnius Mental Health Center, Vilnius,  LT-10309,  Lithuania; Recruiting
      Klaipeda Psychiatric Hospital, Klaipeda,  LT-91251,  Lithuania; Recruiting
      Medical Center “Neuromeda”, Kaunas,  LT-3000,  Lithuania; Recruiting
Netherlands
      Meander Medisch Centrum, Amersfoort,  3816 CP,  Netherlands; Recruiting
Poland
      Uniwersytet Medyczny w Łodzi, Łódż,  91-229,  Poland; Recruiting
      Wojewódzki Specjalistyczny Szpital, Morawica,  26-026,  Poland; Recruiting
      Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kutnie, Kutno,  99-300,  Poland; Recruiting
      Specjalistyczny Publiczny Psychiatryczny Zakład Opieki, Choroszcz,  16-070,  Poland; Recruiting
      Wojewódzki Szpital Psychiatryczny, GdaDsk,  80-282,  Poland; Recruiting
      Wojewódzki Ośrodek Lecznictwa Psychiatrycznego, Toruń,  87-100,  Poland; Recruiting
      Inventiva Biomedical and Sport Research, Tuszyn,  95080,  Poland; Recruiting
South Africa
      Westdene Research Center, Bloemfontein,  9301,  South Africa; Recruiting
      Vista Clinic, Centurion,  South Africa; Recruiting
      Dey Clinic, Pretoria,  South Africa; Recruiting
      2B Tre Mondi Office Park, Somerset West,  South Africa; Recruiting
United Kingdom
      Fowey River Practice, Fowey,  PL23 1DT,  United Kingdom; Recruiting
      Brannel Surgery, Cornwall,  PL26 7RL,  United Kingdom; Recruiting
      The Alverton Practice, Cornwall,  TR18 4JH,  United Kingdom; Recruiting
      Cape Cornwall Surgery, Penzance,  TR19 7HX,  United Kingdom; Recruiting
      Knowle House Surgery, Crown Hill,  PL5 3JD,  United Kingdom; Recruiting
      Woolwell Medical Centre, Plymouth,  PL6 7TH,  United Kingdom; Recruiting
Yugoslavia
      Institut za mentalno zdravlje, Beograd,  11000,  Yugoslavia; Recruiting
      Klinicko-bolnicki centar “Dr Dragisa Misovic”, Begrad,  11000,  Yugoslavia; Recruiting

Study ID Numbers:  3151A1-309-EU
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  August 31, 2004
ClinicalTrials.gov Identifier:  NCT00090649
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08