Aripiprazole for the Treatment of Refractory Anxiety

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Bristol-Myers Squibb
• Treatments: Aripiprazole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.