Therapies for Treatment-Resistant Panic Disorder Symptoms

This study has been completed.

Study NCT00118417 Information provided by National Institute of Mental Health (NIMH)

First Received: July 6, 2005 Last Updated: June 5, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
Condition:	Panic Disorder
Interventions:	Drug: Clonazepam Drug: Sertraline Behavioral: Cognitive behavioral therapy

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
All Participants	No text entered.

Baseline Measures

	All Participants
Number of Participants [units: participants]	42
Age [units: participants]
<=18 years	0
Between 18 and 65 years	42
>=65 years	0
Age [units: years] Mean ± Standard Deviation	37.7 ± 11.2
Gender [units: participants]
Female	24
Male	18
Region of Enrollment [units: participants]
United States	42

Outcome Measures

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1. Primary:

Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6) [ Measured at baseline and after Phase 1 (6 weeks) ]

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2. Primary:

Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12) [ Measured after Phase 1 (Week 6) and Phase 2 (Week 12) ]

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3. Primary:

Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24) [ Measured after Phase 2 (Week 12) and Phase 3 (Week 24) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:

Name/Title: Naomi M. Simon, MD
Organization: Massachusetts General Hospital
phone: 617-726-7913
e-mail: nsimon@partners.org

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