A double-blind, placebo-controlled, parallel-group, flexible-dose study of venlafaxine extended release capsules in adult outpatients with panic disorder. 2009

Michael R Liebowitz, and Gregory Asnis, and Richard Mangano, and Evan Tzanis
Department of Psychiatry, Columbia University, New York, NY 10025, USA. mrl1945@aol.com

OBJECTIVE To evaluate the efficacy, safety, and tolerability of venlafaxine extended release (ER) in short-term treatment of panic disorder. METHODS In this multicenter, double-blind study, conducted from April 2001 to December 2002, 343 adult outpatients who met criteria for panic disorder (with and without agoraphobia) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, were randomly assigned to flexible-dose venlafaxine ER (75-225 mg/d) or placebo for 10 weeks (N = 155 per group, intent-to-treat population). The primary outcome measure was the percentage of panic-free patients as assessed using the Sheehan Panic and Anticipatory Anxiety Scale. Key secondary measures included the Panic Disorder Severity Scale (PDSS) score and Clinical Global Impressions-Improvement (CGI-I) scale response (score = 1 or 2). Last-observation-carried-forward data were analyzed, and statistical significance was set at p <or= .05. RESULTS At week 10, the percentage of patients who were free from full-symptom panic attacks was 52% in the venlafaxine ER group and 43% in the placebo group (p = .11). Mean change from baseline in PDSS total score was significantly (p = .006) greater for the venlafaxine ER group (-9.3) than for the placebo group (-7.5), and significantly (p = .03) more venlafaxine ER-treated patients achieved CGI-I response (71%) than did those receiving placebo (59%) at week 10. Treatment with venlafaxine ER was generally safe and well tolerated. Adverse events were the primary or secondary cause for discontinuation for 7 placebo patients (4%) and 12 venlafaxine ER patients (7%). CONCLUSIONS Venlafaxine ER appears to be effective, safe, and well tolerated in short-term treatment of panic disorder, although the results fell just short of significance on the primary outcome measure. BACKGROUND clinicaltrials.gov Identifier: NCT00038896.

UI MeSH Term Description Entries
D011795 Surveys and Questionnaires Collections of data obtained from voluntary subjects. The information usually takes the form of answers to questions, or suggestions. Community Survey,Nonrespondent,Questionnaire,Questionnaires,Respondent,Survey,Survey Method,Survey Methods,Surveys,Baseline Survey,Community Surveys,Methodology, Survey,Nonrespondents,Questionnaire Design,Randomized Response Technique,Repeated Rounds of Survey,Respondents,Survey Methodology,Baseline Surveys,Design, Questionnaire,Designs, Questionnaire,Methods, Survey,Questionnaire Designs,Questionnaires and Surveys,Randomized Response Techniques,Response Technique, Randomized,Response Techniques, Randomized,Survey, Baseline,Survey, Community,Surveys, Baseline,Surveys, Community,Techniques, Randomized Response
D003511 Cyclohexanols Monohydroxy derivatives of cyclohexanes that contain the general formula R-C6H11O. They have a camphorlike odor and are used in making soaps, insecticides, germicides, dry cleaning, and plasticizers. Cyclohexanol
D003692 Delayed-Action Preparations Dosage forms of a drug that act over a period of time by controlled-release processes or technology. Controlled Release Formulation,Controlled-Release Formulation,Controlled-Release Preparation,Delayed-Action Preparation,Depot Preparation,Depot Preparations,Extended Release Formulation,Extended Release Preparation,Prolonged-Action Preparation,Prolonged-Action Preparations,Sustained Release Formulation,Sustained-Release Preparation,Sustained-Release Preparations,Timed-Release Preparation,Timed-Release Preparations,Controlled-Release Formulations,Controlled-Release Preparations,Extended Release Formulations,Extended Release Preparations,Slow Release Formulation,Sustained Release Formulations,Controlled Release Formulations,Controlled Release Preparation,Controlled Release Preparations,Delayed Action Preparation,Delayed Action Preparations,Formulation, Controlled Release,Formulations, Controlled Release,Prolonged Action Preparation,Release Formulation, Controlled,Release Formulations, Controlled,Sustained Release Preparation,Timed Release Preparation,Timed Release Preparations
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004334 Drug Administration Schedule Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience. Administration Schedule, Drug,Administration Schedules, Drug,Drug Administration Schedules,Schedule, Drug Administration,Schedules, Drug Administration
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000069470 Venlafaxine Hydrochloride A cyclohexanol and phenylethylamine derivative that functions as a SEROTONIN AND NORADRENALINE REUPTAKE INHIBITOR (SNRI) and is used as an ANTIDEPRESSIVE AGENT. 1-(2-(dimethylamino)-1-(4-methoxyphenyl)ethyl)cyclohexanol HCl,Cyclohexanol, 1-(2-(dimethylamino)-1-(4-methoxyphenyl)ethyl)-, hydrochloride,Dobupal,Efexor,Effexor,Sila-Venlafaxine,Trevilor,Vandral,Venlafaxine,Wy 45030,Wy-45,030,Wy-45030,Hydrochloride, Venlafaxine,Sila Venlafaxine,Wy 45,030,Wy45,030,Wy45030
D000553 Ambulatory Care Health care services provided to patients on an ambulatory basis, rather than by admission to a hospital or other health care facility. The services may be a part of a hospital, augmenting its inpatient services, or may be provided at a free-standing facility. Outpatient Care,Outpatient Health Services,Clinic Visits,Health Services, Outpatient,Outpatient Services,Services, Outpatient Health,Urgent Care,Care, Ambulatory,Care, Outpatient,Care, Urgent,Cares, Urgent,Clinic Visit,Health Service, Outpatient,Outpatient Health Service,Outpatient Service,Service, Outpatient,Service, Outpatient Health,Services, Outpatient,Urgent Cares,Visit, Clinic,Visits, Clinic
D012720 Severity of Illness Index Levels within a diagnostic group which are established by various measurement criteria applied to the seriousness of a patient's disorder. Illness Index Severities,Illness Index Severity
D016584 Panic Disorder A type of anxiety disorder characterized by unexpected panic attacks that last minutes or, rarely, hours. Panic attacks begin with intense apprehension, fear or terror and, often, a feeling of impending doom. Symptoms experienced during a panic attack include dyspnea or sensations of being smothered; dizziness, loss of balance or faintness; choking sensations; palpitations or accelerated heart rate; shakiness; sweating; nausea or other form of abdominal distress; depersonalization or derealization; paresthesias; hot flashes or chills; chest discomfort or pain; fear of dying and fear of not being in control of oneself or going crazy. Agoraphobia may also develop. Similar to other anxiety disorders, it may be inherited as an autosomal dominant trait. Panic Attacks,Attack, Panic,Attacks, Panic,Disorder, Panic,Disorders, Panic,Panic Attack,Panic Disorders

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