Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: sertraline 50 mg daily; sertraline 100 mg daily; Placebo 50 or 100 mg
Intervention description: 50 mg daily; 100 mg daily; 50mg or 100mg matching placebo
Intervention MeSH terms: Sertraline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: sertraline; pharmacotherapy; geriatric

Summary:

      Generalized anxiety disorder (GAD) is a very common disorder in the geriatric population with
      prevalence rates reaching 7% and even higher rates of 8% among elderly veterans. However,
      despite such high prevalence treating clinicians are presently forced to address treatment
      issues in this population without the guidance of scientific data. This proposal aims to
      begin to address this void.

      In light of emerging information regarding efficacy of the newer anti anxiety agents,
      specifically the selective serotonin reuptake inhibitors (SSRIs), in the treatment of young
      adult GAD patients it is time to prospectively evaluate the safety and efficacy of these
      medications in the treatment of elderly GAD patients. Therefore, this study will examine the
      effects and safety of the SSRI sertraline at different doses (50mg and 100mg per day) for
      older patients with GAD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females of any race, ages 60 years and older.

          -  Willingness to accept randomization.

          -  Subjects who meet current (Diagnostic and Statistical Manual of Psychiatric Disorders
             forth edition (DSM-IV) criteria for a principal diagnosis of GAD

          -  Patients must have a minimum of a "moderately ill" rating on the Clinicians Global
             Impression-Severity Scale for GAD.

          -  Patients will have a score of 10 or more on the Hospital Anxiety and Depression Rating
             Scale (HADS) Anxiety subscale.

          -  Subjects entering the study will be free of psychotropic medications.

        Exclusion Criteria:

          -  Subjects with DSM-IV current major depressive episode will be excluded.

          -  Subjects who exhibit suicidal ideation or are judged to be a significant suicide risk.

          -  Subjects who meet DSM-IV criteria for a substance (drug and alcohol) abuse and
             dependence disorder within the past 6 months

          -  Subjects who meet current or past DSM-IV criteria for psychotic disorder, or bipolar
             disorder.

          -  Subjects who meet DSM-IV criteria for dementia.

          -  Subjects with DSM-IV current major depressive episode will be excluded.

          -  Subjects who exhibit suicidal ideation or are judged to be a significant suicide risk.

          -  Subjects who meet DSM-IV criteria for a substance (drug and alcohol) abuse and
             dependence disorder within the past 6 months

          -  Subjects who meet current or past DSM-IV criteria for psychotic disorder, or bipolar
             disorder.

          -  Subjects who meet DSM-IV criteria for dementia.