Phase 4
Completed N=42
Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly
Source: ClinicalTrials.gov NCT00701675 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Comparisons of End of Study HAM-A Score Means for Sertraline 50 mg vs Placebo, Sertraline 100 mg vs Placebo, and Sertraline 50 mg vs. Sertraline 100 mg — 10.638; 10.008; 9.357 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparisons of End of Study HAM-A Score Means for Sertraline 50 mg vs Placebo, Sertraline 100 mg vs Placebo, and Sertraline 50 mg vs. Sertraline 100 mg |
10.638; 10.008; 9.357 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00701675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.