Aripiprazole for the Treatment of Refractory Anxiety
|ClinicalTrials.gov Identifier: NCT00438386|
Recruitment Status : Completed
First Posted : February 22, 2007
Last Update Posted : August 10, 2009
|Condition or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder Panic Disorder||Drug: Aripiprazole||Phase 4|
Accruing evidence demonstrates that the anxiety disorders are common and associated with significant morbidity and impairment. Although current first-line interventions are effective, many patients remain at least somewhat symptomatic, and some respond not at all, despite initial treatment. For instance, Generalized Anxiety Disorder (GAD) is a common distressing and disabling condition affecting 5% of the population. It is typically characterized by a chronic course and associated with significant psychosocial impairment and decreased quality of life (Simon and Pollack 2000). Although a number of therapeutic agents have demonstrated efficacy in the treatment of GAD, only a minority of anxious patients experience remission with initial treatment.
Panic disorder with or without agoraphobia is a common anxiety disorder, occurring in 3.5 % of the population (Kessler, et al., 1994). Although the study of panic disorder has advanced in recent years, with the availability of a growing number of treatments with reported efficacy in clinical trials and practice, acute and longitudinal follow-up studies of patients with panic disorder suggest that many individuals remain symptomatic despite treatment (Pollack and Otto, 1994). However, there is no systematic data currently available to guide the treatment of patients with panic disorder who remain symptomatic after initial intervention.
Thus, one purpose of this study is to examine the efficacy of the addition of aripiprazole, for the treatment of patients with GAD or panic disorder who remain refractory despite a treatment trial with an anxiolytic (e.g. antidepressant, benzodiazepine, buspirone). Aripiprazole is a novel antipsychotic agent with potent effects at the serotonergic, as well as dopaminergic receptor, and a more favorable side effect profile than standard neuroleptics, including a low potential to cause extrapyramidal symptoms.
The study period is a 9-week, acute treatment phase. Patients who meet inclusion criteria will receive aripiprazole for 8 weeks. Treatment will be initiated with 2.5 mg/day at the baseline visit, 5 mg/day aripiprazole for the first week and flexibly titrated up to a maximum of 30 mg/day over the next six weeks. Patients will be seen weekly for the first three weeks of this phase of treatment, and then at 2-week intervals for the remainder of the study.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aripiprazole for the Treatment of Refractory Anxiety: Impact on Clinical Outcomes, Resilience and Neuroendocrinologic Parameters|
|Study Start Date :||April 2005|
|Actual Study Completion Date :||June 2007|
- Hamilton Anxiety Rating Scale
- Clinician Global Impression-Severity
- Connor Davidson Resilience Scale
- Panic Disorder Severity Scale
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438386
|United States, Massachusetts|
|Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Mark H Pollack, M.D.||Massachusetts General Hospital|