Aripiprazole for the Treatment of Refractory Anxiety

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00438386
• Date of registration: 20/02/2007
• Prospective Registration: No
• Primary sponsor: Massachusetts General Hospital
• Public title: Aripiprazole for the Treatment of Refractory Anxiety
• Scientific title: Aripiprazole for the Treatment of Refractory Anxiety: Impact on Clinical Outcomes, Resilience and Neuroendocrinologic Parameters
• Date of first enrolment: April 2005
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00438386
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Mark H Pollack, M.D.
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Generalized Anxiety Disorder

Panic Disorder

Intervention(s)

Drug: Aripiprazole

Primary Outcome(s)

Clinician Global Impression-Severity

Connor Davidson Resilience Scale

Hamilton Anxiety Rating Scale

Secondary Outcome(s)

Panic Disorder Severity Scale

Secondary ID(s)

2004-P-000935

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb