Aripiprazole for the Treatment of Refractory Anxiety
|First Received Date ICMJE||February 20, 2007|
|Last Updated Date||August 7, 2009|
|Start Date ICMJE||April 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00438386 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Panic Disorder Severity Scale|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Aripiprazole for the Treatment of Refractory Anxiety|
|Official Title ICMJE||Aripiprazole for the Treatment of Refractory Anxiety: Impact on Clinical Outcomes, Resilience and Neuroendocrinologic Parameters|
The purpose of this study is to determine whether aripiprazole is effective in the treatment of refractory panic and generalized anxiety disorder.
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 ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Intervention ICMJE||Drug: Aripiprazole|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||June 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 75 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00438386|
|Other Study ID Numbers ICMJE||2004-P-000935|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Mark H Pollack, M.D., Massachusetts General Hospital|
|Study Sponsor ICMJE||Massachusetts General Hospital|
|Collaborators ICMJE||Bristol-Myers Squibb|
|Information Provided By||Massachusetts General Hospital|
|Verification Date||August 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP