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Completed

NCT Number: NCT00118417

Therapies for Treatment-Resistant Panic Disorder Symptoms

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

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Key information

Conditions

Panic Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clonazepam

Drug

Participants will receive clonazepam.

Sertraline

Drug

Participants will receive sertraline.

Cognitive behavioral therapy

Behavioral

Participants will receive cognitive behavioral therapy

Primary outcomes

  1. Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6)

    Time frame: Measured at baseline and after Phase 1 (6 weeks)

    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.

  2. Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12)

    Time frame: Measured after Phase 1 (Week 6) and Phase 2 (Week 12)

    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.

  3. Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24)

    Time frame: Measured after Phase 2 (Week 12) and Phase 3 (Week 24)

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Treatment Refractory Panic Disorder

Important dates

Study start
1999
Primary completion
2007
Study completion
2007
First posted
Jul 11, 2005
Registry last updated
Jun 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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