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 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.
- Diagnosis of panic disorder
- 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