A Study of Duloxetine in Elderly Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Duloxetine; Placebo
Intervention description: Administered by mouth, daily for 10 weeks; Administered by mouth, daily for 10 weeks
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 291.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: GAD; Generalized Anxiety Disorder; Anxiety

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.