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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00118417 |
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 |
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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 |
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 |
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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.
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Drug: Sertraline
Participants will receive sertraline.
Behavioral: Cognitive behavioral therapy
Participants will receive cognitive behavioral therapy
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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.
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Drug: Clonazepam
Participants will receive clonazepam.
Drug: Sertraline
Participants will receive sertraline.
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Naomi M. Simon, MD, MSc | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Naomi M. Simon, MD, MSc ) |
Study ID Numbers: | K23 MH01831, DSIR AT-CD |
Study First Received: | July 6, 2005 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00118417 History of Changes |
Health Authority: | United States: Federal Government |
Selective serotonin reuptake inhibitor Anxiety Pharmacotherapy Cognitive behavioral therapy CBT |
Neurotransmitter Agents Panic Disorder Anxiety Disorders Mental Disorders Clonazepam Psychotropic Drugs |
Sertraline Serotonin Uptake Inhibitors Antidepressive Agents Anticonvulsants Serotonin |
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 |