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Trial record 18 of 179 for:    "Panic Disorder"

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

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ClinicalTrials.gov Identifier: NCT00438971
Recruitment Status : Completed
First Posted : February 22, 2007
Results First Posted : December 19, 2013
Last Update Posted : April 27, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Mark H. Pollack, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Panic Disorder
Intervention Drug: Duloxetine
Enrollment 15
Recruitment Details 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 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.
Arm/Group Title Duloxetine
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 17
Completed 15
Not Completed 2
Arm/Group Title Duloxetine
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  93.3%
>=65 years
1
   6.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
41.1  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
9
  60.0%
Male
6
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
Panic Disorder Severity Scale (PDSS) - Primary Outcome  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants
14.2  (4.28)
Clinical Global Impression of Severity scale (CGI-S)  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants
4.80  (0.67)
Panic Attack Scale (PAS)  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants
3.90  (2.38)
1.Primary Outcome
Title Panic Disorder Severity Scale (PDSS)
Hide Description The PDSS contains seven items assessing multiple dimensions of panic disorder severity, including (a) frequency of panic attacks, (b) distress during panic attacks, (c) anticipatory anxiety, (d) agoraphobic fear and avoidance, (e) interoceptive fear and avoidance, (f) impairment of work functioning, and (g) impairment of social functioning. The PDSS ranges from 0 to 28, with higher ratings reflecting greater degrees of symptom severity.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.13  (5.26)
2.Secondary Outcome
Title Clinical Global Impression of Severity Scale (CGI-S)
Hide Description The CGI-S is a clinician-rated instrument used to assess global severity of symptoms. The CGI-S ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Remission was defined strictly as a CGI-S score of 1 or 2 (not at all ill or borderline ill) and zero panic attacks at endpoint.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.47  (1.3)
3.Secondary Outcome
Title Panic Attack Scale (PAS)
Hide Description The PAS is a measure that assesses participants' total number of panic attacks (situational and unexpected with full and limited symptoms), as well as anticipatory anxiety, since last visit. There is no total score.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.90  (1.44)
4.Other Pre-specified Outcome
Title Montgomery Asberg Depression Rating Scale (MADRS)
Hide Description The MADRS is a 10-item clinician rating of depressive symptoms. Scores range from 0 to 60, with higher scores reflecting greater symptom severity.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.07  (6.68)
5.Other Pre-specified Outcome
Title Beck Anxiety Inventory (BAI)
Hide Description The BAI is a 21-item self-report measure of anxiety with a focus on somatic symptoms. Total scores range from 0 to 63, with higher scores reflecting greater symptom severity.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.7  (13.7)
6.Other Pre-specified Outcome
Title Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Hide Description The Q-LES-Q is a self-report measure of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. Only the first 14 items are included in scoring, which ranges from 14 to 70, with higher scores reflecting greater enjoyment and satisfaction. The last two items are not included in the total score but are standalone items.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
49.3  (12.8)
7.Other Pre-specified Outcome
Title Sheehan Disability Scale (SDS)
Hide Description The SDS is a 3-item measure with each item rated on a 10-point scale. The SDS measures the extent to which work/school, social life, and home life or family responsibilities are impaired by symptoms. Total scores range from 0 to 30, with higher scores reflecting greater impairment.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.40  (8.61)
8.Other Pre-specified Outcome
Title Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)
Hide Description The LIFE-RIFT is a brief measure of psychosocial functioning in work, interpersonal relations, satisfaction, and recreation. Scores on the LIFE-RIFT can range from 4, indicating very good functioning (no impairment) in all of the 4 component areas, to 20, indicating very poor functioning (severe impairment) in all of the 4 areas.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.33  (3.63)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine
Hide Arm/Group Description 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.
All-Cause Mortality
Duloxetine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine
Affected / at Risk (%) # Events
Total   1/15 (6.67%)    
General disorders   
Increased Anxiety Leading to Hospitalization [1]  1/15 (6.67%)  1
[1]
Patient presented to the Emergency Department with increased panic attacks and anxiety after he called EMS for another student with a suspected injury. This situational increase in anxiety was not likely to be associated with study drug.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Duloxetine
Affected / at Risk (%) # Events
Total   13/15 (86.67%)    
General disorders   
Appetite Decrease  1/15 (6.67%) 
Appetite Increase  1/15 (6.67%) 
Constipation  2/15 (13.33%) 
Dry Mouth  2/15 (13.33%) 
Dyspepsia  1/15 (6.67%) 
Nausea  3/15 (20.00%) 
Weight Gain  1/15 (6.67%) 
Blurred Vision  1/15 (6.67%) 
Headache  2/15 (13.33%) 
Jitteriness  2/15 (13.33%) 
Anxiety  1/15 (6.67%) 
Sexual Dysfunction  3/15 (20.00%) 
Urinary Hesitation  2/15 (13.33%) 
Insomnia  2/15 (13.33%) 
Sedation  4/15 (26.67%) 
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
Other Publications:
Responsible Party: Mark H. Pollack, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438971     History of Changes
Other Study ID Numbers: 2006-P-000263
First Submitted: February 20, 2007
First Posted: February 22, 2007
Results First Submitted: July 19, 2013
Results First Posted: December 19, 2013
Last Update Posted: April 27, 2016