A Study of Duloxetine in Elderly Generalized Anxiety Disorder

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 score of greater than or equal to 9, no item in the Raskin Depression Scale (CAS)may be >3, and the Covi Anxiety Scale score must be greater than the Raskin Depression Scale (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 patient 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 DSM-IV TR Axis I diagnosis other than GAD, with the exception of comorbid social phobia or specific phobia.

  • (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 patients 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• Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine within the past year or patients with a lack of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 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.