NCT00438386

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 10, 2009

Status Verified

August 1, 2009

First QC Date

February 20, 2007

Last Update Submit

August 7, 2009

Conditions

Generalized Anxiety DisorderPanic Disorder

Keywords

Generalized Anxiety DisorderPanic DisorderAnxiety DisorderAripiprazole

Outcome Measures

Primary Outcomes (3)

  • Hamilton Anxiety Rating Scale

  • Clinician Global Impression-Severity

  • Connor Davidson Resilience Scale

Secondary Outcomes (1)

  • Panic Disorder Severity Scale

Interventions

AripiprazoleDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

  • Simon NM, Pollack MH. The Current Status of the Treatment of Panic Disorder: Pharmacotherapy and Cognitive-Behavioral Therapy. Psych Ann 30(11): 689-696, 2000.

    BACKGROUND

  • Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry. 1994 Jan;51(1):8-19. doi: 10.1001/archpsyc.1994.03950010008002.

    PMID: 8279933BACKGROUND

  • Pollack, M, Otto, M. Long-Term Pharmacologic Treatment of Panic Disorder. Psychiatric Annals 24: 291-298, 1994.

    BACKGROUND

MeSH Terms

Conditions

Generalized Anxiety DisorderPanic DisorderAnxiety Disorders

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mark H Pollack, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

April 1, 2005

Study Completion

June 1, 2007

Last Updated

August 10, 2009

Record last verified: 2009-08

Locations

US(1)