Status:
COMPLETED
Aripiprazole for the Treatment of Refractory Anxiety
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Generalized Anxiety Disorder
Panic Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether aripiprazole is effective in the treatment of refractory panic and generalized anxiety disorder.
Detailed Description
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 re...
Eligibility Criteria
Inclusion
- Male and female outpatients, age 18-75.
- Diagnosis of Generalized Anxiety Disorder (GAD) or Panic Disorder (PD) with or without Agoraphobia.
- For GAD: Hamilton Anxiety Rating Scale score greater than or equal to 16, and for PD: MGH Anchored Panic CGI Severity Rating greater than or equal to 4.
- Hamilton Depression Scale score less than or equal to 18.5) Clinical Global Impression of Severity score Score equal to or greater than 4.
- History of persistent anxiety despite at least 8 weeks of an adequate (or highest tolerated) dose of anxiolytic pharmacotherapy. This is operationalized to include an antidepressant (e.g., paroxetine 20 mg/d; imipramine 150 mg/d or phenelzine 60 mg/d or their equivalent) or a benzodiazepine (e.g., clonazepam 2 mg/d or its equivalent). The dose of medication should be stable for at least 2 weeks prior to evaluation.
- Willingness and ability to comply with the requirements of the study protocol.
Exclusion
- Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months).
- Patients with current or history of bipolar disorder, schizophrenia or other psychotic conditions.
- Patients with a history of alcohol or substance abuse or dependence within the last six months or a positive toxicology screen for drugs of abuse at baseline.
- Patients with significant unstable medical illness or illness which results in HPA axis dysregulation, or other neurohormonal dysregulation.
- Severe personality disorders likely to interfere with study participation.
- Ongoing psychotherapy directed toward the treatment of the primary anxiety disorder.
- History of hypersensitivity to aripiprazole, or \> 1 previous treatment failure for anxiety with atypical antipsychotics. Concomitant treatment with other antipsychotics
- Patients exhibiting suicidality as evidenced by a score greater than 2 on item #3 of the HAM-D.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00438386
Start Date
April 1 2005
End Date
June 1 2007
Last Update
August 10 2009
Active Locations (1)
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1
Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital
Boston, Massachusetts, United States, 02114