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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00546923 |
To examine the efficacy and safety of venlafaxine XR in the treatment of physical and emotional symptoms in patients with an operationally-defined diagnosis of multisomatoform disorder (MSD).
Condition | Intervention | Phase |
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Anxiety Disorders Depression |
Drug: Venlafaxine XR |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Pilot Study To Evaluate The Efficacy And Safety Of Venlafaxine Extended-Release In Depressed And Anxious Patients With Multiple, Unexplained Somatic Symptoms |
Estimated Enrollment: | 210 |
Study Start Date: | August 2004 |
Study Completion Date: | June 2006 |
The purpose of this study is to examine the efficacy and safety of venlafaxine XR in the treatment of physical and emotional symptoms in patients with an operationally-defined diagnosis of MSD. Primary efficacy will be evaluated using the PHQ-15 scale, and secondary efficacy will be evaluated using the HAM-D17, HAM-A, CGI, MQOL-PS, VAS and SF-36 evaluation scales. Assessment scales and questionnaires will be administered at specified clinical visits between screening and Week 12 (or discontinuation).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 0600B-101568 |
Study First Received: | October 18, 2007 |
Last Updated: | October 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00546923 History of Changes |
Health Authority: | Taiwan: Department of Health |
Neurotransmitter Agents Depression Anxiety Disorders Mental Disorders Venlafaxine Psychotropic Drugs |
Antidepressive Agents, Second-Generation Depressive Disorder Serotonin Uptake Inhibitors Antidepressive Agents Serotonin Behavioral Symptoms |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Depression Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms |
Serotonin Agents Anxiety Disorders Mental Disorders Therapeutic Uses Venlafaxine Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |