Panic DisorderPhase 3NCT00000368
Treatment of Panic Disorder: Long Term Strategies
A Phase 3 study testing Cognitive behavior therapy and Paroxetine or other medication - algorithm used in people with Panic Disorder and Agoraphobia, run by New York State Psychiatric Institute at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Panic Disorder, Agoraphobia
- What is being tested?
- Cognitive behavior therapy and Paroxetine or other medication - algorithm used
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 379 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 1999to Jul 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary diagnosis of Panic disorder with or without Agoraphobia (all levels of agoraphobia are included).
Who cannot join
- 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,
Show all 12Show fewer
- 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.
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Boston University, Department of Psychology, Center for Anxiety and Related Disorders
Boston, Massachusetts
Yale University, Department of Psychiatry, Anxiety Disorders Research Clinic
New Haven, Connecticut
Hillside Hospital Phobia Clinic
New York, New York
University of Pittsburgh, Department of Psychiatry, Panic, Anxiety and Traumatic Grief Program
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Panic Disorder, Agoraphobia
- Being tested
- Cognitive behavior therapy, Paroxetine or other medication - algorithm used
- Keywords
- 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
- Medical subject headings
- Panic Disorder, Agoraphobia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapyBehavioural
Paroxetine or other medication - algorithm usedDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Panic Disorder Severity Scale
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.
Measured: At baseline and major assessment points plus monthly.
Clinical Global Impressions
Commonly used global rating of improvement.
Measured: Monthly, including all nonpretreatment major assessments.
Secondary outcomes (3)
Albany Panic and Phobia Questionnaire
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.
Measured: All major assessment points.
Anxiety Sensitivity Index
This is a 16-item scale that assesses person's tendency to regard physiologic arousal as harmful.
Measured: All major assessments and treatment visits.
Subjective Symptoms Scale
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.
Measured: All major assessment points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startFeb 1999
- Primary completionJul 2004
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Natalia A. Skritskaya, PhD, New York State Psychiatric Institute
- Investigators
- Katherine H. Shear, MD, Study chair, University of PittsburghDavid H Barlow, PhD, Principal investigator, Boston University Department of PsychologyJack Gorman, MD, Principal investigator, Columbia University School of MedicineScott Woods, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000368
- Sponsor's protocol ID
- R01MH045964
- Other IDs
- R01MH045964, R01MH045965, R01MH045966, R01MH045963, DSIR AT-CT
- Status last verified
- Mar 2014
- First submitted
- 2 Nov 1999
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barlow DH, Gorman JM, Shear MK, Woods SW. Cognitive-behavioral therapy, imipramine, or their combination for panic disorder: A randomized controlled trial. JAMA. 2000 May 17;283(19):2529-36. doi: 10.1001/jama.283.19.2529.
PubMed 10815116Shear MK, Brown TA, Barlow DH, Money R, Sholomskas DE, Woods SW, Gorman JM, Papp LA. Multicenter collaborative panic disorder severity scale. Am J Psychiatry. 1997 Nov;154(11):1571-5. doi: 10.1176/ajp.154.11.1571.
PubMed 9356566Gorman JM. A 28-year-old woman with panic disorder. JAMA. 2001 Jul 25;286(4):450-7. doi: 10.1001/jama.286.4.450. No abstract available.
PubMed 11466124Grilo CM, Money R, Barlow DH, Goddard AW, Gorman JM, Hofmann SG, Papp LA, Shear MK, Woods SW. Pretreatment patient factors predicting attrition from a multicenter randomized controlled treatment study for panic disorder. Compr Psychiatry. 1998 Nov-Dec;39(6):323-32. doi: 10.1016/s0010-440x(98)90043-8.
PubMed 9829138Huppert JD, Bufka LF, Barlow DH, Gorman JM, Shear MK, Woods SW. Therapists, therapist variables, and cognitive-behavioral therapy outcome in a multicenter trial for panic disorder. J Consult Clin Psychol. 2001 Oct;69(5):747-55. doi: 10.1037//0022-006x.69.5.747.
PubMed 11680551Hofmann SG, Barlow DH, Papp LA, Detweiler MF, Ray SE, Shear MK, Woods SW, Gorman JM. Pretreatment attrition in a comparative treatment outcome study on panic disorder. Am J Psychiatry. 1998 Jan;155(1):43-7. doi: 10.1176/ajp.155.1.43.
PubMed 9433337Payne LA, White KS, Gallagher MW, Woods SW, Shear MK, Gorman JM, Farchione TJ, Barlow DH. SECOND-STAGE TREATMENTS FOR RELATIVE NONRESPONDERS TO COGNITIVE BEHAVIORAL THERAPY (CBT) FOR PANIC DISORDER WITH OR WITHOUT AGORAPHOBIA-CONTINUED CBT VERSUS SSRI: A RANDOMIZED CONTROLLED TRIAL. Depress Anxiety. 2016 May;33(5):392-9. doi: 10.1002/da.22457. Epub 2015 Dec 10.
PubMed 26663632
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Panic Disorder: Long Term Strategies
- ClinicalTrials.gov ID
- NCT00000368
- Acronym / sponsor ID
- R01MH045964
- Conditions
- Panic Disorder, Agoraphobia
- Keywords
- Adult, Cognitive Behavioral Therapy, Pharmacotherapy, Long term treatment, Remission and relapse, Male, Panic Disorder, Paroxetine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 1999
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 3 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary diagnosis of Panic disorder with or without Agoraphobia (all levels of agoraphobia are included).
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavior therapy | Behavioural | – |
| Paroxetine or other medication - algorithm used | Drug | – |
Primary outcome
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.
3 secondary outcomes
Albany Panic and Phobia Questionnaire
Time frame: All major assessment points.
Anxiety Sensitivity Index
Time frame: All major assessments and treatment visits.
Subjective Symptoms Scale
Time frame: All major assessment points
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
- Background: PubMed 10815116Barlow DH, Gorman JM, Shear MK, Woods SW. Cognitive-behavioral therapy, imipramine, or their combination for panic disorder: A randomized controlled trial. JAMA. 2000 May 17;283(19):2529-36. doi: 10.1001/jama.283.19.2529.
- Background: PubMed 9356566Shear MK, Brown TA, Barlow DH, Money R, Sholomskas DE, Woods SW, Gorman JM, Papp LA. Multicenter collaborative panic disorder severity scale. Am J Psychiatry. 1997 Nov;154(11):1571-5. doi: 10.1176/ajp.154.11.1571.
- Background: PubMed 11466124Gorman JM. A 28-year-old woman with panic disorder. JAMA. 2001 Jul 25;286(4):450-7. doi: 10.1001/jama.286.4.450. No abstract available.
- Background: PubMed 9829138Grilo CM, Money R, Barlow DH, Goddard AW, Gorman JM, Hofmann SG, Papp LA, Shear MK, Woods SW. Pretreatment patient factors predicting attrition from a multicenter randomized controlled treatment study for panic disorder. Compr Psychiatry. 1998 Nov-Dec;39(6):323-32. doi: 10.1016/s0010-440x(98)90043-8.
- Background: PubMed 11680551Huppert JD, Bufka LF, Barlow DH, Gorman JM, Shear MK, Woods SW. Therapists, therapist variables, and cognitive-behavioral therapy outcome in a multicenter trial for panic disorder. J Consult Clin Psychol. 2001 Oct;69(5):747-55. doi: 10.1037//0022-006x.69.5.747.
- Background: PubMed 9433337Hofmann SG, Barlow DH, Papp LA, Detweiler MF, Ray SE, Shear MK, Woods SW, Gorman JM. Pretreatment attrition in a comparative treatment outcome study on panic disorder. Am J Psychiatry. 1998 Jan;155(1):43-7. doi: 10.1176/ajp.155.1.43.
- Derived from this study: PubMed 26663632Payne LA, White KS, Gallagher MW, Woods SW, Shear MK, Gorman JM, Farchione TJ, Barlow DH. SECOND-STAGE TREATMENTS FOR RELATIVE NONRESPONDERS TO COGNITIVE BEHAVIORAL THERAPY (CBT) FOR PANIC DISORDER WITH OR WITHOUT AGORAPHOBIA-CONTINUED CBT VERSUS SSRI: A RANDOMIZED CONTROLLED TRIAL. Depress Anxiety. 2016 May;33(5):392-9. doi: 10.1002/da.22457. Epub 2015 Dec 10.
- Center for Anxiety and Related Disorders \[Boston Study Site\]Link provided by the sponsor.
- Yale Anxiety Disorders Research Clinic \[New Haven Study site\]Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine H. Shear, MD study chair
University of Pittsburgh
David H Barlow, PhD principal investigator
Boston University Department of Psychology
Jack Gorman, MD principal investigator
Columbia University School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive behavior therapy and Paroxetine or other medication - algorithm used in people with Panic Disorder and Agoraphobia, run by New York State Psychiatric Institute at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Panic Disorder Severity Scale (time frame: At baseline and major assessment points plus monthly.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000368, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.