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DVS-233 SR For Prevention Of Depressive Relapse 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 DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder Clinical research trials and DVS-233 SR For Prevention Of Depressive Relapse 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 DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder. DVS-233 SR For Prevention Of Depressive Relapse 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 DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder clinical trial. Participants oftentimes recieve the finest healthcare available for their DVS-233 SR For Prevention Of Depressive Relapse 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 > "D" Clinical Trials Conditions > DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder  DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder
DVS-233 SR For Prevention Of Depressive Relapse 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 efficacy and safety of DVS-233 SR versus placebo treatment in reducing the relapse rate of depressive symptoms in subjects with major depressive disorder (MDD), and to compare the percentages of relapse in terms of time to relapse between DVS-233 SR and placebo treatment groups by using survival analysis. Secondary Objective: To assess the response of subjects on DVS-233 SR versus placebo for the clinical global evaluation, functionality, general well-being, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] < 7).
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 in the open-label phase: - 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 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 psychiatric diagnoses that are not allowable.) - Depressive symptoms for at least 30 days before entry in the study. - Minimum screening and baseline (study day –1) total scores of 20 on the Hamilton Psychiatric Rating Scale for depression, 17 items (HAM-D17). - Minimum screening and baseline (study day –1) total scores of 2 on item 1 (depressed mood) of the Hamilton Psychiatric Rating Scale for Depression (HAM-D17). - Minimum screening and baseline (study day –1) scores of 4 on the Clinical Global Impressions-Severity scale (CGI-S). - Signed and dated informed consent before any screening procedures. Inclusion criterion in the double-blind phase of the study: - Should have responded to the open-label treatment with DVS-233 SR as shown by having a HAM-D17 total score equal to or less than 11 on study day 84. Exclusion Criteria: - Treatment with DVS-233 SR at any time in the past. - Treatment with venlafaxine (immediate release [IR] or 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 Scale 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 (e.g., 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), laboratory tests. Clinically important abnormalities on 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 17.1 and 17.2 (Permitted Treatment and Prohibited Treatment) for treatments and associated timeframes.
Total Enrollment:
Location and Contact Information:
Pharmacology Research Institute *Recruiting*
Northridge, California, 91324
United States
Recruiting Daniel Grosz 562-795-6975
San Antonio Center for Clinical Research *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Thomas Weiss 210-614-5561
NorthCoast Clinical Trials, Inc. *Recruiting*
Beechwood, Ohio, 44124
United States
Recruiting Bijan Bastani 216-514-1803
Comprehensive NeuroScience, Inc. *Recruiting*
Sarasota, Florida, 34232
United States
Recruiting Mary Stedman 941-342-8288
Research Site *Recruiting*
Denver, Colorado, 80212
United States
Recruiting Leslie Moldauer 303-477-1880
Cunningham Clinical Research Associate *Recruiting*
Edwardsville, Illinois, 62025
United States
Recruiting Lynn Cunningham 618-659-0292
Psychopharmacology Research *Recruiting*
St. Paul, Minnesota, 55101
United States
Recruiting Elizabeth Reeve 651-221-1271
Summit Research Network (Michigan), Inc. *Recruiting*
Okemos, Michigan, 48864
United States
Recruiting Robert Bielski 517-349-5505
Psychiatric Research Institute *Recruiting*
Wichita, Kansas, 67214
United States
Recruiting Ahsan Khan 316-291-4774
Louisianna State University Medical Center *Recruiting*
Shreveport, Louisiana, 71130-3932
United States
Recruiting Arthur Freeman 318-675-6061
Carman Research *Recruiting*
Smyrna, Georgia, 30080
United States
Recruiting John Carman 770-333-0093
Dean Foundation *Recruiting*
Middleton, Wisconsin, 53562
United States
Recruiting Leslie Taylor 608-827-2316
University  of  Pennsylvania  Medical  Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Karl Rickels 215-662-2842
Irvine Center for Clinical Research *Recruiting*
Irvine, California, 92618
United States
Recruiting Elly Lee 714-753-1663
Southwestern Research, Inc. *Recruiting*
Beverly Hills, California, 90210
United States
Recruiting Dennis Munjack 310-858-7448
Additional Information:
Study ID Numbers: 3151A1-302-WW;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075257
Other Major Depressive Disorder Studies:
1. Open-Label Treatment with Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients with Major Depression
2. Open Label Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial
3. Treatment of Patients with Major Depressive Disorder with an Investigational Compound
4. Efficacy And Safety Of Three Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder
5. Study Of Depression In Adults
Related Studies:
Other Major Depressive Disorder Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder
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