Treatment of Panic Disorder: Long Term Strategies

Completed · Phase 3

Conditions studied: Panic Disorder, Agoraphobia

In brief

Cognitive behavior therapy (CBT) with or without medication has been used in the treatment of panic disorder (PD). The purpose of this study is 1) to determine whether nine months of maintenance cognitive-behavior therapy (CBT) significantly improves the likelihood of sustained improvement; and 2) to determine the acute acceptability and efficacy of medication therapy or continued CBT alone among patients who fail to respond sufficiently to an initial course of CBT alone. It has been found that patients with PD respond as well to CBT or medication alone as they do to a combination of the two. Since the combined treatments are expensive and CBT is associated with less risk of medical toxicity compared to medications, CBT alone will be used first. All patients will first receive CBT alone. If the patient responds to this therapy, the patient will be assigned randomly (like tossing a coin) to 1 of 2 groups. One group will continue to receive CBT (maintenance therapy) for 9 months. The other group of responders will not receive any further therapy. If a patient does not respond to CBT alone, he/she will be assigned randomly to 1 of 2 different groups. One group will receive paroxetine; the other will continue to receive CBT for a longer period. The response to treatment will be evaluated to see which regimen works best to treat PD. The study will last approximately 3 years. An individual may be eligible for this study if he/she has panic disorder with no more than mild agoraphobia (fear of being in public places) and is at least 18 years old.

Key facts

Study ID

NCT00000368

Run by

New York State Psychiatric Institute

People needed

379

Starts

1999-02-01

Expected to finish

2004-07-01

Last updated by the study team

2014-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• primary diagnosis of Panic disorder with or without Agoraphobia (all levels of agoraphobia are included).

You may not qualify if…

• 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.

Where it is running

• Yale University, Department of Psychiatry, Anxiety Disorders Research Clinic — New Haven, Connecticut, United States
• Boston University, Department of Psychology, Center for Anxiety and Related Disorders — Boston, Massachusetts, United States
• Hillside Hospital Phobia Clinic — New York, New York, United States
• University of Pittsburgh, Department of Psychiatry, Panic, Anxiety and Traumatic Grief Program — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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