Clinical trial NCT00118417: Therapies for Treatment-Resistant Panic Disorder Symptoms
Official title: Treatment Refractory Panic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Panic Disorder
Keywords: Selective serotonin reuptake inhibitor
Anxiety
Pharmacotherapy
Cognitive behavioral therapy
CBT
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-07-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6)
timeFrame: Measured at baseline and after Phase 1 (6 weeks)
measure: Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12)
timeFrame: Measured after Phase 1 (Week 6) and Phase 2 (Week 12)
measure: Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24)
timeFrame: Measured after Phase 2 (Week 12) and Phase 3 (Week 24)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Naomi M. Simon, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.4088/JCP.08m04485blu. Epub 2009 Oct 6.