Therapies for Treatment-Resistant Panic Disorder Symptoms

NCT00118417 | Completed Phase 2 Results

• 2 other identifiers: K23MH001831DSIR AT-CD
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Panic Disorder

Keywords

Selective serotonin reuptake inhibitor; Anxiety; Pharmacotherapy; Cognitive behavioral therapy; CBT

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

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; Behavioral: 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; Drug: Sertraline

Interventions

Clonazepam DRUG

Participants will receive clonazepam.

2

Sertraline DRUG

Participants will receive sertraline.

1; 2

Cognitive behavioral therapy BEHAVIORAL

Participants will receive cognitive behavioral therapy

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of panic disorder

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Simon NM, Otto MW, Worthington JJ, Hoge EA, Thompson EH, Lebeau RT, Moshier SJ, Zalta AK, Pollack MH. Next-step strategies for panic disorder refractory to initial pharmacotherapy: a 3-phase randomized clinical trial. J Clin Psychiatry. 2009 Nov;70(11):1563-70. doi: 10.4088/JCP.08m04485blu. Epub 2009 Oct 6.

  PMID: 19814948 DERIVED

MeSH Terms

Conditions

Panic Disorder; Anxiety Disorders

Interventions

Clonazepam; Sertraline; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Power in Phase 2 limited detection to a large effect size. High drop-out for increased SSRI dose may indicate poor tolerability. Effectiveness of adding an SSRI to initial CBT was unexamined, limiting generalization to community treatment decisions.

Results Point of Contact

• Title: Naomi M. Simon, MD
• Organization: Massachusetts General Hospital

nsimon@partners.org

617-726-7913

Study Officials

• Naomi M. Simon, MD, MSc

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Anxiety and Traumatic Stress Disorders

Study Record Dates

• First Submitted: July 6, 2005
• First Posted: July 11, 2005
• Study Start: March 1, 1999
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: June 11, 2014
• Results First Posted: July 28, 2009

Record last verified: 2014-06

Locations

US (1)