Therapies for Treatment-Resistant Panic Disorder Symptoms - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00118417

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment Refractory Panic Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Panic Disorder

Drug Information available for: Serotonin Sertraline hydrochloride Sertraline Clonazepam

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]
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 ]
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 ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

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
1: Experimental 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
2: Experimental 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 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

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

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

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Naomi M. Simon, MD, MSc

Massachusetts General Hospital

More Information

Additional Information:

Click here for more information about the Center for Anxiety and Traumatic Stress Related Disorders This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Massachusetts General Hospital ( Naomi M. Simon, MD, MSc )
Study ID Numbers:	K23 MH001831, DSIR AT-CD
Study First Received:	July 6, 2005
Results First Received:	June 5, 2009
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00118417 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Selective serotonin reuptake inhibitor
Anxiety
Pharmacotherapy
Cognitive behavioral therapy
CBT

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Panic Disorder
Serotonin Agents

Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Clonazepam
GABA Agents
Sertraline
Central Nervous System Agents
Antidepressive Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 27, 2009