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
  Purpose

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


Condition Intervention Phase
Panic Disorder
Drug: Clonazepam
Drug: Sertraline
Behavioral: Cognitive behavioral therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment Refractory Panic Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 46
Study Start Date: March 1999
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Sertraline
Participants will receive sertraline.
Behavioral: Cognitive behavioral therapy
Participants will receive 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.
Drug: Clonazepam
Participants will receive clonazepam.
Drug: Sertraline
Participants will receive sertraline.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118417

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Naomi M. Simon, MD, MSc Massachusetts General Hospital
  More Information

Additional Information:
No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Naomi M. Simon, Director, Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00118417     History of Changes
Other Study ID Numbers: K23 MH001831, K23MH001831, DSIR AT-CD
Study First Received: July 6, 2005
Results First Received: June 5, 2009
Last Updated: June 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Selective serotonin reuptake inhibitor
Anxiety
Pharmacotherapy
Cognitive behavioral therapy
CBT

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders
Clonazepam
Sertraline
Serotonin Uptake Inhibitors
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on August 21, 2014