Trial Outcomes & Findings for The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder (NCT NCT00438971)

NCT ID: NCT00438971

Last Updated: 2016-04-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2016-04-27

Participant Flow

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.

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.

Participant milestones

Measure	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.
Overall Study STARTED	17
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Duloxetine n=15 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	41.1 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Panic Disorder Severity Scale (PDSS) - Primary Outcome	14.2 units on a scale STANDARD_DEVIATION 4.28 • n=5 Participants
Clinical Global Impression of Severity scale (CGI-S)	4.80 units on a scale STANDARD_DEVIATION 0.67 • n=5 Participants
Panic Attack Scale (PAS)	3.90 units on a scale STANDARD_DEVIATION 2.38 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Measure	Duloxetine n=15 Participants 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.
Panic Disorder Severity Scale (PDSS)	9.13 units on a scale Standard Deviation 5.26

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Measure	Duloxetine n=15 Participants 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.
Clinical Global Impression of Severity Scale (CGI-S)	3.47 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Measure	Duloxetine n=15 Participants 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.
Panic Attack Scale (PAS)	0.90 units on a scale Standard Deviation 1.44

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

The MADRS is a 10-item clinician rating of depressive symptoms. Scores range from 0 to 60, with higher scores reflecting greater symptom severity.

Outcome measures

Measure	Duloxetine n=15 Participants 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.
Montgomery Asberg Depression Rating Scale (MADRS)	9.07 units on a scale Standard Deviation 6.68

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

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.

Outcome measures

Measure	Duloxetine n=15 Participants 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.
Beck Anxiety Inventory (BAI)	14.7 units on a scale Standard Deviation 13.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

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.

Outcome measures

Measure	Duloxetine n=15 Participants 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.
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)	49.3 units on a scale Standard Deviation 12.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

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.

Outcome measures

Measure	Duloxetine n=15 Participants 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.
Sheehan Disability Scale (SDS)	9.40 units on a scale Standard Deviation 8.61

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

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.

Outcome measures

Measure	Duloxetine n=15 Participants 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.
Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)	9.33 units on a scale Standard Deviation 3.63

Adverse Events

Duloxetine

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Duloxetine n=15 participants at risk 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.
General disorders Increased Anxiety Leading to Hospitalization	6.7% 1/15 • Number of events 1

Other adverse events

Measure	Duloxetine n=15 participants at risk 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.
General disorders Appetite Decrease	6.7% 1/15
General disorders Appetite Increase	6.7% 1/15
General disorders Constipation	13.3% 2/15
General disorders Dry Mouth	13.3% 2/15
General disorders Dyspepsia	6.7% 1/15
General disorders Nausea	20.0% 3/15
General disorders Weight Gain	6.7% 1/15
General disorders Blurred Vision	6.7% 1/15
General disorders Headache	13.3% 2/15
General disorders Jitteriness	13.3% 2/15
General disorders Anxiety	6.7% 1/15
General disorders Sexual Dysfunction	20.0% 3/15
General disorders Urinary Hesitation	13.3% 2/15
General disorders Insomnia	13.3% 2/15
General disorders Sedation	26.7% 4/15

Additional Information

Dr. Mark Pollack

Rush University

Phone: 312-942-5372

Email: mark_pollack@rush.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place