Aripiprazole for the Treatment of Refractory Anxiety

Completed · Phase 4

Conditions studied: Generalized Anxiety Disorder, Panic Disorder

In brief

The purpose of this study is to determine whether aripiprazole is effective in the treatment of refractory panic and generalized anxiety disorder.

Key facts

Study ID

NCT00438386

Run by

Massachusetts General Hospital

Starts

2005-04-01

Expected to finish

2007-06-01

Last updated by the study team

2009-08-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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