Clinical Trial: Study Of DVS-233 SR And Venlafaxine ER In Adult Outpatients With Major Depressive Disorder

This study is currently recruiting patients.

Sponsored by: Wyeth
Information provided by: Wyeth

Purpose

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

MedlinePlus related topics:  Mental Health

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study Of DVS-233 SR And Venlafaxine ER In Adult Outpatients With Major Depressive Disorder

Eligibility

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.

Location and Contact Information


Belgium
      Centre Hospitalier de la Citadelle, Liège,  4000,  Belgium; Recruiting
Dr. Joseph Lejeune  +32 4225 6145 

      Clinique Notre Dame, Tournay,  B-7500,  Belgium; Recruiting
Dr. Michel Floris  +32 6925 8395 

      Cliniques Universitaires (UCL) de Mont-Godinne, Yvoir,  B-5530,  Belgium; Recruiting
Prof. Christine Reynaert  +32 8142 3754 

Croatia
      Klinicka bolnica Osijek, Osijek,  31000,  Croatia; Recruiting
Dr Pavo Filakovic  +38 531 551 798 

      Klinicka bolnica Split, Split,  21000,  Croatia; Recruiting
Pr Goran Dodig  +38 521 556 079 

      Klinicki bolnicki centar Rijeka, Rijeka,  51000,  Croatia; Recruiting
Prof Dr Ljiljana Moro  +38 551 333 323 

      Psihijatrijska bolnica Vrapce, Zagreb,  10090,  Croatia; Recruiting
Prof Dr Vera Folnegovic-Smalc  +38 513 780 678 

Estonia
      Mustamäe Health Care Center, Tallinn,  12618,  Estonia; Recruiting
Dr Andres Lehtmets  +372 503 67 41 

      Viljandi Hospital Foundation Psychiatric Clinic, Viljandi,  71024,  Estonia; Recruiting
Dr Riina Jents  +372 534 35 452 

      Jaanson & Lääne Outpatient Clinic, Tartu,  51008,  Estonia; Recruiting
Dr Peeter Lääne  +37 251 56 556 

France
      Centre Hospitalier Saint-Anne, Paris,  75014,  France; Recruiting
Pr Julien-Daniel Guelfi  +33 1 45 65 83 69 

      Research Site, Rennes,  35000,  France; Recruiting
Dr Bertrand Baranovsky  +33 2 99 79 38 00 

      Research Site, Joue-les-Tours,  37300,  France; Recruiting
Dr Didier Deroche  +33 2 47 67 20 99 

      Immeuble Impérial, La Valette-du-Var,  83160,  France; Recruiting
Dr Christophe Dufour  +33 4 94 08 61 82 

      Research Site, Tours,  37000,  France; Recruiting
Dr Michel Faure  +33 2 47 61 00 22 

      Research Site, Caen,  14000,  France; Recruiting
Dr Joël Langeard  +33 2 31 50 09 10 

      Immeuble Le Sully, Marseille,  13012,  France; Recruiting
Dr Eric Perreard  +33 4 91 44 43 02 

      Résidence Saint-Michel, Douai,  59500,  France; Recruiting
Dr Bruno Scottez  +33 2 27 98 25 26 

Germany
      Praxis für Psychiatrie, Berlin,  13053,  Germany; Recruiting
Dr Peter Franz  +49-(0)-30- 9869-7741 

      Praxis für Psychiatrie, Berlin,  13156,  Germany; Recruiting
Dr Alexander Schulze  +49-(0)-30-4747-1055 

      Klinik und Poliklinik für Psychiatrie, Göttingen,  D- 37075,  Germany; Recruiting
Dr Eckart Rüther  +49-(0)-551-39-6601 

      Praxis für Psychiatrie, Hildesheim,  31134,  Germany; Recruiting
Dr Dolores Backhaus  +49-(0)-5121-57441 

      Emovis GmbH, Berlin,  10629,  Germany; Recruiting
Dr Bettina Bergtholdt  +49-(0)-30-310 1360 

Latvia
      Liepaja Psychoneurological Hospital, Liepaja,  LV-3401,  Latvia; Recruiting
Dr Imants Zeme  +371 34 25311 

      Psychoneurological hospital of Jelgava, Jelgava,  LV-3008,  Latvia; Recruiting
Dr Paulis Revelis  +371 3007 198 

      Riga Mental Health Care Center, Riga,  LV-1005,  Latvia; Recruiting
Prof Raisa Andrezina  +371 7080131 

      Psychoneurological Hospital of Strenci, Strenci,  4730,  Latvia; Recruiting
Dr. Andris Arajs  +371 4 731 580 

Lithuania
      Vilnius Mental Health Center, Vilnius,  LT-10309,  Lithuania; Recruiting
Dr.Liaudginas Erdvilas Radavicius  +370 52 313 746 

      Klaipeda Psychiatric Hospital, Klaipeda,  LT-91251,  Lithuania; Recruiting
Dr Emilis Subata  +370 46 39 77 80 

      Medical Center “Neuromeda”, Kaunas,  LT-3000,  Lithuania; Recruiting
Dr Vanda Liesiene  +370 37 33 15 55 

Netherlands
      Meander Medisch Centrum, Amersfoort,  3816 CP,  Netherlands; Recruiting
Dr. J.M.G. Coppens  +31 33 422 2345 

Poland
      Uniwersytet Medyczny w Łodzi, Łódż,  91-229,  Poland; Recruiting
Prof. Antoni Florkowski  +48 42 6521289 

      Wojewódzki Specjalistyczny Szpital, Morawica,  26-026,  Poland; Recruiting
Dr Marek Cwiakala  +48 413611302 

      Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kutnie, Kutno,  99-300,  Poland; Recruiting
Dr Ryszard Wardenski  +48 24 3558461 

      Specjalistyczny Publiczny Psychiatryczny Zakład Opieki, Choroszcz,  16-070,  Poland; Recruiting
Dr Wlodzimierz Chrzanowski  +48 85 664 7178 

      Wojewódzki Szpital Psychiatryczny, GdaDsk,  80-282,  Poland; Recruiting
Prof. Leszek Bidzan  +48 583446085 

      Wojewódzki Ośrodek Lecznictwa Psychiatrycznego, Toruń,  87-100,  Poland; Recruiting
Dr. Jaroslaw Laczkowski  +48 56 6580709 

      Inventiva Biomedical and Sport Research, Tuszyn,  95080,  Poland; Recruiting
Dr. Jaroslaw Strzelec  +48 42 6144211 

South Africa
      Westdene Research Center, Bloemfontein,  9301,  South Africa; Recruiting
Prof. Carllo A. Gagiano  +27 51 448-5977 

      Vista Clinic, Centurion,  South Africa; Recruiting
Dr. P.U. Ramjee  +27 12 664-0222 

      Dey Clinic, Pretoria,  South Africa; Recruiting
Dr. M. Slabber  +27 12 460-3502 

      2B Tre Mondi Office Park, Somerset West,  South Africa; Recruiting
Dr. G.C. Verster  +27 21 852-8927 

United Kingdom
      Fowey River Practice, Fowey,  PL23 1DT,  United Kingdom; Recruiting
Dr. Alan Middleton  +44 1726 832451 

      Brannel Surgery, Cornwall,  PL26 7RL,  United Kingdom; Recruiting
Dr. John Cecil  +44 1726 822254 

      The Alverton Practice, Cornwall,  TR18 4JH,  United Kingdom; Recruiting
Dr. John Ryan  +44 1736 363741 

      Cape Cornwall Surgery, Penzance,  TR19 7HX,  United Kingdom; Recruiting
Dr. Adam Ellery  +44 1736 788306 

      Knowle House Surgery, Crown Hill,  PL5 3JD,  United Kingdom; Recruiting
Dr. Tim Hall  +44 1752 793383 

      Woolwell Medical Centre, Plymouth,  PL6 7TH,  United Kingdom; Recruiting
Dr. Paul Fletcher  +44 1752 209030 

Yugoslavia
      Institut za mentalno zdravlje, Beograd,  11000,  Yugoslavia; Recruiting
Prof. Ivana Timotijevic  +38 111 3239 153 

      Klinicko-bolnicki centar “Dr Dragisa Misovic”, Begrad,  11000,  Yugoslavia; Recruiting
Prof. Vladimir Diligenski  +38 111 266 1002 

More Information

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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