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Adult Outpatients with Major Depressive Disorder Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Adult Outpatients with Major Depressive Disorder conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Adult Outpatients with Major Depressive Disorder Clinical research trials and Adult Outpatients with Major Depressive Disorder medical trials take place in many of places throughout 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Adult Outpatients with Major Depressive Disorder. Adult Outpatients with Major Depressive Disorder Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Adult Outpatients with Major Depressive Disorder clinical trial. Test subjects typically obtain the finest healthcare available for their Adult Outpatients with Major Depressive Disorder condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Adult Outpatients with Major Depressive Disorder  Adult Outpatients with Major Depressive Disorder
Adult Outpatients with Major Depressive Disorder
For Condition: Major Depressive Disorder
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.
Details:
Eligibility:
Study Type: Interventional, Treatment
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 (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). - 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:
Coordinated Research of Florida, Inc. *Recruiting*
Winter Park, Florida, 32789
United States
Recruiting Andrew Cutler 407-644-1165
The Medical Research Network, L.L.C. *Recruiting*
New York City, New York, 10024
United States
Recruiting Michael Liebowitz 212-595-5012
Chicago Center for Clinical Research *Recruiting*
Chicago, Illinois, 60610-4324
United States
Recruiting Jeffrey Ross 312-494-2227
Pacific Clinical Research *Recruiting*
Orange, California, 92868
United States
Recruiting Daniel Zimbroff 714-771-3100
Center for Emotional Fitness *Recruiting*
Moorestown, New Jersey, 08057
United States
Recruiting Leon Rosenberg 865-778-9084
University of Texas Southwestern Medical Center at Dallas *Recruiting*
Dallas, Texas, 75390-9101
United States
Recruiting Madhukar Trivedi 214-648-6449
The George Washington University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20037
United States
Recruiting Karen Weihs 202-994-2624
New Britain General Hospital *Recruiting*
New Britain, Connecticut, 06050
United States
Recruiting Mahlon Hale 860-224-5597
Feiger Health Research Center *Recruiting*
Wheat Ridge, Colorado, 80033
United States
Recruiting Alan Feiger 303-425-4298
Creighton University, Department of Psychiatry *Recruiting*
Omaha, Nebraska, 68131
United States
Recruiting Shashi Bhatia 402-345-7100
Summit Research Network, Inc. *Recruiting*
Okemos, Michigan, 48864
United States
Recruiting Robert Bielski 248-427-1688
Pharmacology Research Institute *Recruiting*
Newport Beach, California, 92660-2452
United States
Recruiting Jon Heiser 949-752-7910
Comprehensive NeuroScience, Inc. *Recruiting*
St. Petersburg, Florida, 33702
United States
Recruiting Margarita Nunez 727-576-8474
Southeastern Pennsylvania Medical Institute *Recruiting*
Havertown, Pennsylvania, 19083
United States
Recruiting B. Blatt 610-446-0662
Future Search Trials *Recruiting*
Austin, Texas, 78756
United States
Recruiting William Privitera 512-380-9925
Additional Information:
Study ID Numbers: 3151A1-304-US;
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063206
Other Major Depressive Disorder Studies:
1. Pharmacologic Treatment of PTSD in Sexually Abused Children
2. Efficacy And Safety Of Two Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder
3. Depression Study In Adults
4. Study Of Depression In Adults
5. Brain Function in Mentally Ill Adolescents
Related Studies:
Other Major Depressive Disorder Clinical Trials
Other Colorado Clinical Trials
Other Wheat Ridge Clinical Trials
Adult Outpatients with Major Depressive Disorder
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