a study of duloxetine in elderly generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to test the safety and efficacy of duloxetine versus placebo in elderly patients suffering from generalized anxiety disorder (gad).


Eligibility criteria:
inclusion criteria: * have gad based on diagnostic criteria and not suffer from an adjustment disorder or anxiety disorder not otherwise specified. symptoms of gad should not be situational in nature. * have a mini mental state examination (mmse) score of at least 24 at screening. * have a clinical global impressions of severity (cgi-severity) score of greater than or equal to 4 at screening and randomization. * have a covi anxiety scale (cas) score of greater than or equal to 9, no item in the raskin depression scale (rds) may be \>3, and the cas score must be greater than the rds at screening. * have a hospital anxiety and depression scale (hads) anxiety subscale score of greater than or equal to 10 at screening. * have a degree of understanding such that the participant can communicate intelligibly with the investigator and study coordinator. * are judged to be reliable to keep all appointments and able to swallow all required medication without opening or crushing. exclusion criteria: * have any current and primary diagnostic and statistical manual of mental disorders, fourth edition-text revised (dsm-iv tr) axis i diagnosis other than gad, with the exception of comorbid social phobia or specific phobia. * major depressive disorder (mdd) within the past 6 months, or * panic disorder, posttraumatic stress disorder (ptsd), or an eating disorder within the past year, or * obsessive compulsive disorder (ocd), bipolar affective disorder, psychosis, factitious disorder, or somatoform disorders during their lifetime. * the presence of an axis ii disorder, or history of antisocial behavior, or participants who, in the opinion of the investigator, are poor medical or psychiatric risks for study compliance. * have organic mental disorder or mental retardation diagnosis. * use of benzodiazepine within 14 days prior to randomization. * are judged clinically to be at serious risk of harm to self or others. * are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. * have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine within the past year or participants with a lack of response or intolerability to duloxetine (for any approved indication) at a clinically appropriate dose for a minimum of 4 weeks. * have a history of alcohol or any psychoactive substance abuse or dependence within the past 6 months. * excessively use caffeine, in the opinion of the investigator. * have a positive urine drug screen (uds) for any substances of abuse at screening. * have a serious medical illness. * have any acute liver injury or severe cirrhosis. * have an abnormal thyroid-stimulating hormone (tsh) concentrations. * have initiated psychotherapy or changed intensity of psychotherapy or other non-drug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or at any time during the study. * have taken any excluded medication within 7 days prior to randomization. * have been treated with a monoamine oxidase inhibitor (maoi) or fluoxetine within 30 days of randomization or potentially need to use an maoi during the study or within 5 days of discontinuation of study drug. * exhibit a lack of response of the current episode of gad to 2 or more adequate trials of antidepressants, benzodiazepines, or other anxiolytics at a clinically appropriate dose for a minimum of 4 weeks. * have a history of severe allergies, hypersensitivity to duloxetine or to any of the inactive ingredients; multiple adverse drug reactions; transcranial magnetic stimulation (tms); history of seizures; or history of psychosurgery or electroconvulsive therapy (ect) within 12 months. * have discontinued hormone replacement therapy within the previous 3 months. * have uncontrolled narrow-angle glaucoma.

Keywords: gad generalized anxiety disorder anxiety