Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2007

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 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 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.

Intervention(s) in this Clinical Trial

• Drug: Clonazepam
  • Participants will receive clonazepam.
• Drug: Sertraline
  • Participants will receive sertraline.
• Behavioral: Cognitive behavioral therapy
  • Participants will receive cognitive behavioral therapy

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.

Primary Measures

• Panic disorder symptoms
  • Time Frame: Measured every 1 to 4 weeks during the study, with follow up assessments at 3, 6, 12 and 24 months after endpoint
    Safety Issue?: Yes

Secondary Measures

• Clinical global improvement
  • Time Frame: Measured every 1 to 4 weeks during the study, with follow up assessments at 3, 6, 12 and 24 months after endpoint
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Naomi M. Simon, MD, MSc Principal Investigator Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00118417

Study ID Number: K23 MH01831

ClinicalTrials.gov Identifier: NCT00118417

Health Authority: United States: Federal Government

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