Therapies for Treatment-Resistant Panic Disorder Symptoms

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00118417
First received: July 6, 2005
Last updated: June 5, 2014
Last verified: June 2014

July 6, 2005
June 5, 2014
March 1999
October 2007   (final data collection date for primary outcome measure)
  • Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6) [ Time Frame: Measured at baseline and after Phase 1 (6 weeks) ] [ Designated as safety issue: Yes ]
    This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.
  • Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12) [ Time Frame: Measured after Phase 1 (Week 6) and Phase 2 (Week 12) ] [ Designated as safety issue: No ]
    This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.
  • Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24) [ Time Frame: Measured after Phase 2 (Week 12) and Phase 3 (Week 24) ] [ Designated as safety issue: No ]
    This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.
Panic disorder symptoms
Complete list of historical versions of study NCT00118417 on ClinicalTrials.gov Archive Site
Not Provided
Clinical global improvement
Not Provided
Not Provided
 
Therapies for Treatment-Resistant Panic Disorder Symptoms
Treatment Refractory Panic Disorder

This study will determine the effectiveness of different treatments for panic disorder symptoms in individuals who still have symptoms after initial treatment with medication.

Panic disorder is a serious condition that may cause significant psychological and physical distress. Many patients with panic disorder remain symptomatic despite initial intervention. Unfortunately, little data is available to guide health care providers in "next-step" treatment approaches. This study will evaluate the effectiveness of treatments for individuals with panic disorder that is resistant to initial treatment with selective serotonin reuptake inhibitors (SSRIs).

This study will last 24 weeks and will comprise three phases. In Phase 1, participants will receive the SSRI sertraline for 6 weeks. Phase 1 will be used to determine participants' resistance to treatment. During Phase 1, participants will begin a medication schedule and symptom diary and will have weekly study visits to assess regimen adherence and any side effects they may be experiencing. In Phase 2, participants will be randomly assigned to 6 weeks of one of two treatments: sertraline at an elevated dose from that given in Phase 1 or a sertraline and placebo regimen. During Phase 2, participants will have 3 study visits. Self-report scales and diary entries will be used to assess panic disorder symptoms and medication side effects. In Phase 3, participants will be randomly assigned to receive either cognitive behavioral therapy (CBT) or sertraline and clonazepam for 12 weeks. All participants will have weekly study visits during Phase 3. Questionnaires and self-report scales will be used to assess participants at the end of Phase 3.

Study hypothesis: Combined selective serotonin reuptake inhibitors (SSRIs) and benzodiazepine treatment, increasing the dose of SSRI, and the addition of cognitive behavioral therapy (CBT) each may have benefits for patients with panic disorder who remain symptomatic after initial treatment with SSRIs.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Panic Disorder
  • Drug: Clonazepam
    Participants will receive clonazepam.
  • Drug: Sertraline
    Participants will receive sertraline.
  • Behavioral: Cognitive behavioral therapy
    Participants will receive cognitive behavioral therapy
  • Experimental: 1
    Participants in phase II will receive sertraline, or an equivalent medication, up to 100 mg plus a placebo pill. Participants in phase III will receive the same medication with cognitive behavioral therapy.
    Interventions:
    • Drug: Sertraline
    • Behavioral: Cognitive behavioral therapy
  • Experimental: 2
    Participants in phase II will receive sertraline, or equivalent medication, up to 200 mg. Participants in phase III they will receive the same medication with flexible clonazepam augmentation.
    Interventions:
    • Drug: Clonazepam
    • Drug: Sertraline
Simon NM, Otto MW, Worthington JJ, Hoge EA, Thompson EH, Lebeau RT, Moshier SJ, Zalta AK, Pollack MH. Next-step strategies for panic disorder refractory to initial pharmacotherapy: a 3-phase randomized clinical trial. J Clin Psychiatry. 2009 Nov;70(11):1563-70. Epub 2009 Oct 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of panic disorder

Exclusion Criteria:

  • History of bipolar disorder, schizophrenia, psychosis, or delusional disorders
  • Post-traumatic stress disorder diagnosis within 6 months prior to study entry
  • Current use of psychotropic medications
  • Current use of cognitive behavioral therapy
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00118417
K23 MH001831, K23MH001831, DSIR AT-CD
Not Provided
Naomi M. Simon, Massachusetts General Hospital
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Naomi M. Simon, MD, MSc Massachusetts General Hospital
Massachusetts General Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP