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Efficacy And Safety Of Two Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Efficacy And Safety Of Two Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Efficacy And Safety Of Two Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder Clinical research trials and Efficacy And Safety Of Two Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Efficacy And Safety Of Two Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder. Efficacy And Safety Of Two Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Efficacy And Safety Of Two Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder clinical trial. Participants oftentimes recieve the finest healthcare available for their Efficacy And Safety Of Two Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Efficacy And Safety Of Two Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder  Efficacy And Safety Of Two Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Efficacy And Safety Of Two Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder
For Condition: Major Depressive Disorder
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: Primary Objective: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo. Secondary Objective: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general wellbeing, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] less than or equal to 7) versus those subjects receiving placebo.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Outpatients. - Men and women 18 to 75 years of age, inclusive. Sexually active women participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. - 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 prior to the screening visit. - Minimum screening and study day –1 (baseline) scores of 20 on the Hamilton Psychiatric Rating Scale for Depression (HAMD17). - 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). - A Covi Anxiety Scale total score greater than the Raskin Depression Scale total score at screening or at study day –1 (baseline). A Covi Anxiety score greater than 3 on any single item or a total score greater than 9 at screening or at study day –1 (baseline). - Depression associated with the presence of an organic mental disorder due to a general medical condition or a neurological disorder. - History of a seizure disorder other than a single childhood febrile seizure. - History or presence of clinically important hepatic or renal disease or other medical disease that might confound the study or be detrimental to the subject (eg, clinically important cardiac arrhythmia, uncontrolled diabetes, uncontrolled hypertension). - History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or history of surgery known to interfere with the absorption or excretion of drugs. - History of neoplastic disorder (within 2 years), with the exception of basal or squamous cell carcinoma of the skin. - Known presence of raised intraocular pressure or history of narrow-angle glaucoma. - Major acute illness during the 90 days before screening. - Myocardial infarction within 180 days before screening. - Clinically important abnormalities on screening physical examination, electrocardiogram (ECG), or laboratory tests. Clinically important abnormalities on screening 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. - Use of prohibited treatments. Refer to Excluded Treatments chart and Sections 16.1 and 16.2 (Permitted Treatment and Prohibited Treatment) for treatments and associated timeframes.
Total Enrollment:
Location and Contact Information:
Research Center *Recruiting*
Caen, , 14000
France
Recruiting Study Coordinator +33 2 31862121
Research Center *Recruiting*
Saint-Cyr-l'Ecole, , 78210
France
Recruiting Study Coordinator +33 134605051
CHS du Jura *Recruiting*
Dôle cedex, , 39108
France
Recruiting Study Coordinator +33 3 84 72 77 70
Research Center *Recruiting*
Orvault, , 44700
France
Recruiting Study Coordinator +33 2 40 16 00 01
Additional Information:
Study ID Numbers: 3151A1-308-WW;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073762
Other Major Depressive Disorder Studies:
1. Treatment Resistant Depression Study
2. Treatment of Patients with Major Depressive Disorder with an Investigational Compound
3. Study Of Depression In Adults
4. Brain Function in Mentally Ill Adolescents
5. Neuroanatomy of Emotion Regulation in Major Depressive Disorder
Related Studies:
Other Major Depressive Disorder Clinical Trials
Other Clinical Trials
Other Dôle cedex Clinical Trials
Efficacy And Safety Of Two Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder
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