Treatment of Panic Disorder: Long Term Strategies
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| ClinicalTrials.gov Identifier: NCT00000368 |
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Recruitment Status :
Completed
First Posted : November 3, 1999
Last Update Posted : March 18, 2014
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Panic Disorder Agoraphobia | Behavioral: Cognitive behavior therapy Drug: Paroxetine or other medication - algorithm used | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 379 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Treatment of Panic Disorder: Long Term Strategies |
| Study Start Date : | February 1999 |
| Actual Primary Completion Date : | July 2004 |
| Actual Study Completion Date : | July 2004 |
- Panic Disorder Severity Scale [ Time Frame: At baseline and major assessment points plus monthly. ]This is a 7-item scale providing ratings of core features of panic disorder and the degree of work and social impairment/interference due to the disorder.
- Clinical Global Impressions [ Time Frame: Monthly, including all nonpretreatment major assessments. ]Commonly used global rating of improvement.
- Albany Panic and Phobia Questionnaire [ Time Frame: All major assessment points. ]This is a 27-item scale consisting of three subscales that assess fear of agoraphobic situations, social situations, and situations and activities that produce bodily sensations commonly feared by individuals with panic disorder.
- Anxiety Sensitivity Index [ Time Frame: All major assessments and treatment visits. ]This is a 16-item scale that assesses person's tendency to regard physiologic arousal as harmful.
- Subjective Symptoms Scale [ Time Frame: All major assessment points ]This is an individual's rating of the extent to which anxiety symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000368
| United States, Connecticut | |
| Yale University, Department of Psychiatry, Anxiety Disorders Research Clinic | |
| New Haven, Connecticut, United States | |
| United States, Massachusetts | |
| Boston University, Department of Psychology, Center for Anxiety and Related Disorders | |
| Boston, Massachusetts, United States | |
| United States, New York | |
| Hillside Hospital Phobia Clinic | |
| New York, New York, United States | |
| United States, Pennsylvania | |
| University of Pittsburgh, Department of Psychiatry, Panic, Anxiety and Traumatic Grief Program | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Study Chair: | Katherine H. Shear, MD | University of Pittsburgh | |
| Principal Investigator: | David H Barlow, PhD | Boston University Department of Psychology | |
| Principal Investigator: | Jack Gorman, MD | Columbia University School of Medicine | |
| Principal Investigator: | Scott Woods, MD | Yale University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Natalia A. Skritskaya, PhD, Co-investigator, New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00000368 |
| Other Study ID Numbers: |
R01MH045964 ( U.S. NIH Grant/Contract ) R01MH045964 ( U.S. NIH Grant/Contract ) R01MH045965 ( U.S. NIH Grant/Contract ) R01MH045966 ( U.S. NIH Grant/Contract ) R01MH045963 ( U.S. NIH Grant/Contract ) DSIR AT-CT |
| First Posted: | November 3, 1999 Key Record Dates |
| Last Update Posted: | March 18, 2014 |
| Last Verified: | March 2014 |
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Adult Cognitive Behavioral Therapy Pharmacotherapy Long term treatment Remission and relapse Male Panic Disorder |
Paroxetine Serotonin Uptake Inhibitors Panic Disorder -- *therapy Panic Disorder -- drug therapy Paroxetine -- *therapeutic use Serotonin Uptake Inhibitors -- *therapeutic use |
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Panic Disorder Agoraphobia Anxiety Disorders Mental Disorders Phobic Disorders Paroxetine Selective Serotonin Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |