Therapies for Treatment-Resistant Panic Disorder Symptoms

Panic Disorder Clinical Trial

Official title:

Treatment Refractory Panic Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118417
• Other study ID #: K23MH001831
• Secondary ID: K23MH001831DSIR
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 6, 2005
• Last updated: June 5, 2014
• Start date: March 1999
• Est. completion date: October 2007

Study information

• Verified date: June 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Panic Disorder

Intervention

Drug:
• Clonazepam
Participants will receive clonazepam.
• Sertraline
Participants will receive sertraline.

Behavioral:
• Cognitive behavioral therapy
Participants will receive cognitive behavioral therapy

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6)	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.	Measured at baseline and after Phase 1 (6 weeks)	Yes
Primary	Change in Panic Disorder Symptoms, Phase 2 (Week 6 - 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.	Measured after Phase 1 (Week 6) and Phase 2 (Week 12)	No
Primary	Change in Panic Disorder Symptoms, Phase 3 (Week 12 - 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.	Measured after Phase 2 (Week 12) and Phase 3 (Week 24)	No

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