Treatment of Panic Disorder: Long Term Strategies

NCT00000368 | Completed Phase 3 DMC

• 5 other identifiers: R01MH045964R01MH045965R01MH045966R01MH045963DSIR AT-CT
• Study Type: interventional
• Target: 379
• Locations: 1 country
• Sites: 4

Brief 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 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.

Conditions

Panic Disorder; Agoraphobia

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

Outcome Measures

Primary Outcomes (2)

• 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.

  At baseline and major assessment points plus monthly.

• Clinical Global Impressions

  Commonly used global rating of improvement.

  Monthly, including all nonpretreatment major assessments.

Secondary Outcomes (3)

• Albany Panic and Phobia Questionnaire

  All major assessment points.

• Anxiety Sensitivity Index

  All major assessments and treatment visits.

• Subjective Symptoms Scale

  All major assessment points

Interventions

Cognitive behavior therapy BEHAVIORAL

Paroxetine or other medication - algorithm used DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Yale University, Department of Psychiatry, Anxiety Disorders Research Clinic

New Haven, Connecticut, United States

Location

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

Boston, Massachusetts, United States

Location

Hillside Hospital Phobia Clinic

New York, New York, United States

Location

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

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (7)

• 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.

  PMID: 10815116 BACKGROUND

• Shear 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.

  PMID: 9356566 BACKGROUND

• Gorman 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.

  PMID: 11466124 BACKGROUND

• Grilo 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.

  PMID: 9829138 BACKGROUND

• Huppert 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.

  PMID: 11680551 BACKGROUND

• Hofmann 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.

  PMID: 9433337 BACKGROUND

• Payne 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.

  PMID: 26663632 DERIVED

Related Links

• Center for Anxiety and Related Disorders \[Boston Study Site\]
• Yale Anxiety Disorders Research Clinic \[New Haven Study site\]

MeSH Terms

Conditions

Panic Disorder; Agoraphobia; Recurrence

Interventions

Cognitive Behavioral Therapy; Paroxetine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Phobic Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Katherine H. Shear, MD

  University of Pittsburgh

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-investigator

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: November 3, 1999
• Study Start: February 1, 1999
• Primary Completion: July 1, 2004
• Study Completion: July 1, 2004
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

US (4)