Completed

Treatment of Panic Disorder: Long Term Strategies

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What is being tested

Cognitive behavior therapy

+ Paroxetine or other medication - algorithm used

BehavioralDrug
Who is being recruted

Anxiety Disorders+6

+ Mental Disorders

+ Pathologic Processes

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: February 1999
See protocol details

Summary

Principal SponsorNew York State Psychiatric Institute
Last updated: March 18, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1999

Actual date on which the first participant was enrolled.

To determine if maintenance CBT produces a more sustained improvement among patients with panic disorder (PD) who respond to an initial course of cognitive behavior therapy (CBT) alone. For those who do not respond sufficiently to CBT alone, to determine if the addition of pharmacotherapy is acceptable and if this improves response among those inadequate responders to CBT alone. This multicenter study builds upon the findings of a prior study comparing imipramine, placebo, CBT, and their combination in the treatment of PD patients with no more than mild agoraphobia. That study found response rates were as high with CBT or imipramine alone as with their combination. Given the added cost of combined treatments, it therefore seems reasonable to begin with monotherapy. Further, following general principles of medical practice, it would be reasonable to initiate treatment with the less invasive cognitive behavioral intervention. It is then important to learn what should be done following initial treatment. All patients initially receive CBT alone. Patients are then randomized into 1 of 2 post-acute studies, depending on response status. Responders are randomized to a maintenance study comparing no maintenance with 9 months of continued CBT. Nonresponders are randomized to a study comparing paroxetine with continued CBT. The following outcomes will be examined: the necessity of maintenance therapy in maintaining response; the ability of adjunct pharmacotherapy to improve the response of patients who did not respond to CBT alone; possible predictors of response and relapse; and possible mediators of response.

NCT00000368
Principal SponsorNew York State Psychiatric Institute
Last updated: March 18, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

379 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Anxiety DisordersMental DisordersPathologic ProcessesPhobic DisordersPathological Conditions, Signs and SymptomsDisease AttributesAgoraphobiaRecurrencePanic Disorder

Criteria

Inclusion Criteria: - primary diagnosis of Panic disorder with or without Agoraphobia (all levels of agoraphobia are included). Exclusion Criteria: current substance abuse or dependence, current active suicidal potential; any history of psychosis, bipolar disorder (I or II) or cyclothymia; pending application or existing medical disability claim; significant cognitive impairment, current uncontrolled general medical illness requiring intervention, psychotherapy directed at anxiety or panic which will not be discontinued by the first treatment visit, and daily use of 2mg of Xanax or equivalent. Exclusion criteria for paroxetine study: hypersensitivity to Selective Serotonin Reuptake Inhibitors (SSRI), pregnancy, lactation, or planned pregnancy during the course of the study, contemporaneous medication that may interfere or interact with paroxetine, prior treatment with therapeutic doses of paroxetine (40mg/d for 1 mo), concurrent treatment with antidepressants.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Yale University, Department of Psychiatry, Anxiety Disorders Research Clinic

New Haven, United StatesOpen Yale University, Department of Psychiatry, Anxiety Disorders Research Clinic in Google Maps

Boston University, Department of Psychology, Center for Anxiety and Related Disorders

Boston, United States

Hillside Hospital Phobia Clinic

New York, United States

University of Pittsburgh, Department of Psychiatry, Panic, Anxiety and Traumatic Grief Program

Pittsburgh, United States
Completed4 Study Centers