Study Of DVS-233 SR And Venlafaxine ER In Adult Outpatients With Major Depressive Disorder - Article Lodine XL
Clinical Trial: Study Of DVS-233 SR And Venlafaxine ER In Adult Outpatients With Major Depressive Disorder
This study is currently recruiting patients.
|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
Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Both
- 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.
- 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
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
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
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
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
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
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
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
Meander Medisch Centrum, Amersfoort, 3816 CP, Netherlands; Recruiting
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
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
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
Institut za mentalno zdravlje, Beograd, 11000, Yugoslavia; Recruiting
Klinicko-bolnicki centar “Dr Dragisa Misovic”, Begrad, 11000, Yugoslavia; Recruiting
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
Cache Date: April 9, 2005