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The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Mark H. Pollack, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00438971
First received: February 20, 2007
Last updated: October 29, 2013
Last verified: October 2013
Results First Received: July 19, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Panic Disorder
Intervention: Drug: Duloxetine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Outpatients 18-75 years of age with a current DSM-IV diagnosis of panic disorder with or without agoraphobia were recruited through hospital and media advertisement between August 2006 and April 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were required to be free of all psychiatric medications except for benzodiazepines initiated at least 2 weeks prior to study initiation and with the dose held stable during the trial. Of the 17 individuals initially enrolled, 2 completed the screening procedure but did not initiate pharmacotherapy and are not included in analyses.

Reporting Groups
  Description
Duloxetine Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.

Participant Flow:   Overall Study
    Duloxetine  
STARTED     17  
COMPLETED     15  
NOT COMPLETED     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Duloxetine Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.

Baseline Measures
    Duloxetine  
Number of Participants  
[units: participants]
  15  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     14  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  41.1  ± 15  
Gender  
[units: participants]
 
Female     9  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     15  
Panic Disorder Severity Scale (PDSS)  
[units: units on a scale]
Mean ± Standard Deviation
  14.2  ± 4.28  
Clinical Global Impression of Severity scale (CGI-S)  
[units: units on a scale]
Mean ± Standard Deviation
  4.80  ± 0.67  
Panic Attack Scale (PAS)  
[units: units on a scale]
Mean ± Standard Deviation
  3.90  ± 2.38  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Panic Disorder Severity Scale (PDSS)   [ Time Frame: 8 weeks ]

2.  Secondary:   Clinical Global Impression of Severity Scale (CGI-S)   [ Time Frame: 8 weeks ]

3.  Secondary:   Panic Attack Scale (PAS)   [ Time Frame: 8 weeks ]

4.  Other Pre-specified:   Montgomery Asberg Depression Rating Scale (MADRS)   [ Time Frame: 8 weeks ]

5.  Other Pre-specified:   Beck Anxiety Inventory (BAI)   [ Time Frame: 8 weeks ]

6.  Other Pre-specified:   Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)   [ Time Frame: 8 weeks ]

7.  Other Pre-specified:   Sheehan Disability Scale (SDS)   [ Time Frame: 8 weeks ]

8.  Other Pre-specified:   Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


Results Point of Contact:  
Name/Title: Dr. Mark Pollack
Organization: Rush University
phone: 312-942-5372
e-mail: mark_pollack@rush.edu


Publications of Results:
Other Publications:


Responsible Party: Mark H. Pollack, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438971     History of Changes
Other Study ID Numbers: 2006-P-000263
Study First Received: February 20, 2007
Results First Received: July 19, 2013
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board