Therapies for Treatment-Resistant Panic Disorder Symptoms
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Panic Disorder
Intervention: Clonazepam (Drug); Sertraline (Drug); Cognitive behavior therapy (Behavioral)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s):
Naomi M. Simon, MD, MSc, Principal Investigator, Affiliation: Massachusetts General Hospital
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.
Clinical Details
Official title: Treatment Refractory Panic Disorder
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Panic disorder symptoms
Secondary outcome: Clinical global improvement
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Click here for more information about the Center for Anxiety and Traumatic Stress Related Disorders
Starting date: March 1999
Ending date: September 2007
Last updated: October 20, 2006
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