A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder
Study Details
Study Description
Brief Summary
To evaluate the efficacy and safety of sertraline compared to paroxetine in patients with panic disorder.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1
|
Drug: sertraline
dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks
Other Names:
|
Active Comparator: 2
|
Drug: Paroxetine
dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase [Baseline and 12 weeks]
Panic and Agoraphobia Scale has 13 items with a 5-point scale (range: 0 to 4). The total possible score is ranged from 0 to 52. The increasing value are considered worse outcome. The scale is grouped into 5 subscores (not including item U in total score): panic attacks ; agoraphobia/avoidance behavior ; anticipatory anxiety; disability; and health worries. Four point difference in reduction of the PAS total score has been identified as not clinically meaningful in the assessment of Panic Disorder symptomatology.
Secondary Outcome Measures
- Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement [12 weeks]
The ratings were rated to compare with baseline by 7-point " 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse". Responder was defined as number of participants who were assessed as "very much improved" or " much improved".
- Mean Change From Baseline in Panic Attack at the End of Treatment Phase [Baseline and 12 weeks]
Panic attacks were defined as having four or more of the following Diagnostic and Statistical Manual of Mental Disorders symptoms. Palpitations or increased heart rate, Sweating, Trembling or shaking, Shortness of breath or smothering sensations, Choking, Chest pain or discomfort, Nausea or upset stomach, Dizziness, unsteady feelings or faintness, Feeling unlike yourself, or detached from a situation and/or like things happening around you are strange and unreal, Fear of going crazy or doing something uncontrolled, Fear of dying, Abnormal sense, Hot flashes or chills.
- Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase [Baseline and 12 weeks]
The Hamilton Anxiety Rating Scale provided a 5-point intensity rating (0=None to 4=Very severe) of anxiety symptoms in 14 items. The increasing values are considered worse outcome. The total possible score is ranged from 0 to 52.
- Number of Participants With Summary of Adverse Events in Treatment Phase [1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug]
Number of sparticipants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants were counted only once per treatment in each row.
- Summary of Adverse Events in Tapering Phase [4 weeks]
Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects were counted only once per treatment in each row.
- Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase [4 weeks]
The percentage of participants divided was calcurated as follows: Devide the number of participants who had experienced new symptoms in Week 16, regardless of causal relationship with the study drug, or worsening of the severity in Week 16 compared with Week 12, by total number of participants in each treatment group.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient who meets diagnosis of Panic Disorder (with or without Agoraphobia) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV).
-
Patients must have experienced at least 4 panic attacks within 4 weeks before screening.
-
At baseline patients with Panic Disorder of total score of 18 or higher on the Panic and Agoraphobia scale (clinician rated version).
Exclusion Criteria:
-
Patients who concurrently have bipolar disorder, schizophrenia, delusional disorder, epilepsy, Major Depression Disorder (MDD), Obsessive Compulsive Disorder (OCD), Seasonal Affective Disorder (SAD) or General Anxiety Disorder (GAD) according to the DSM-IV criteria.
-
Patients who concurrently have depression/depressive state, anxiety disorder and generalized anxiety disorder may be included in the study if the primary diagnosis is identified to be panic disorder
-
Patients with the total score of at least 18 on the Hamilton Depression Rating Scale (HAM-D) (Items 1 to 17) at the start of Screening (Visit 1)
-
Patients who require concomitant drug therapy with psychotropic agents (including benzodiazepines) and monoamine oxidase inhibitor during the period of the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Pfizer Investigational Site | Nagoya | Aichi | Japan | |
2 | Pfizer Investigational Site | Fukuoka-shi | Fukuoka | Japan | |
3 | Pfizer Investigational Site | Kitakyushu-shi | Fukuoka | Japan | |
4 | Pfizer Investigational Site | Kitakyusyu-shi | Fukuoka | Japan | |
5 | Pfizer Investigational Site | Sapporo-Shi | Hokkaido | Japan | |
6 | Pfizer Investigational Site | Sapporo | Hokkaido | Japan | |
7 | Pfizer Investigational Site | Higashiibaraki-gun | Ibaraki | Japan | |
8 | Pfizer Investigational Site | Fujisawa-city | Kanagawa | Japan | |
9 | Pfizer Investigational Site | Sagamihara-Shi | Kanagawa | Japan | |
10 | Pfizer Investigational Site | Yokohama-Shi | Kanagawa | Japan | |
11 | Pfizer Investigational Site | Yokohama | Kanagawa | Japan | |
12 | Pfizer Investigational Site | Kawaguchi-shi | Saitama | Japan | |
13 | Pfizer Investigational Site | Saitama city | Saitama | Japan | |
14 | Pfizer Investigational Site | Chiyoda-ku | Tokyo | Japan | |
15 | Pfizer Investigational Site | Kita-ku | Tokyo | Japan | |
16 | Pfizer Investigational Site | Minato-ku | Tokyo | Japan | |
17 | Pfizer Investigational Site | Musashino | Tokyo | Japan | |
18 | Pfizer Investigational Site | Nakano-Ku | Tokyo | Japan | |
19 | Pfizer Investigational Site | Nakanoku | Tokyo | Japan | |
20 | Pfizer Investigational Site | Setagaya-ku | Tokyo | Japan | |
21 | Pfizer Investigational Site | Shinjuku-ku | Tokyo | Japan | |
22 | Pfizer Investigational Site | Toshima-ku | Tokyo | Japan | |
23 | Pfizer Investigational Site | Nakano-ku | Yokohama | Japan | |
24 | Pfizer Investigational Site | Minato-ku | Japan |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A0501088
Study Results
Participant Flow
Recruitment Details | Participants were screened at 34 centers in Japan. |
---|---|
Pre-assignment Detail | Subjects who experienced at least one panic attack that met the DSM-IV diagnostic criteria per week between the start of the washout/observation period and the start of the double-blind treatment period and who had a total score of 18 or higher on the Panic and Agoraphobia Scale at the start of the double-blind treatment period. |
Arm/Group Title | Sertraline | Paroxetine |
---|---|---|
Arm/Group Description | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. |
Period Title: Treatment Phase | ||
STARTED | 157 | 164 |
COMPLETED | 132 | 122 |
NOT COMPLETED | 25 | 42 |
Period Title: Treatment Phase | ||
STARTED | 132 | 122 |
COMPLETED | 126 | 112 |
NOT COMPLETED | 6 | 10 |
Baseline Characteristics
Arm/Group Title | Sertraline | Paroxetine | Total |
---|---|---|---|
Arm/Group Description | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. | Total of all reporting groups |
Overall Participants | 157 | 162 | 319 |
Age, Customized (participants) [Number] | |||
< 18 years |
0
0%
|
0
0%
|
0
0%
|
18 - 44 years |
119
75.8%
|
126
77.8%
|
245
76.8%
|
45 -64 years |
38
24.2%
|
36
22.2%
|
74
23.2%
|
>= 65 years |
0
0%
|
0
0%
|
0
0%
|
Sex: Female, Male (Count of Participants) | |||
Female |
113
72%
|
109
67.3%
|
222
69.6%
|
Male |
44
28%
|
53
32.7%
|
97
30.4%
|
Outcome Measures
Title | Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase |
---|---|
Description | Panic and Agoraphobia Scale has 13 items with a 5-point scale (range: 0 to 4). The total possible score is ranged from 0 to 52. The increasing value are considered worse outcome. The scale is grouped into 5 subscores (not including item U in total score): panic attacks ; agoraphobia/avoidance behavior ; anticipatory anxiety; disability; and health worries. Four point difference in reduction of the PAS total score has been identified as not clinically meaningful in the assessment of Panic Disorder symptomatology. |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12. Last Observation Carried Forward |
Arm/Group Title | Sertraline | Paroxetine |
---|---|---|
Arm/Group Description | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. |
Measure Participants | 127 | 127 |
Least Squares Mean (95% Confidence Interval) [Scores on scale] |
-17.4
|
-17.0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Sertraline, Paroxetine |
---|---|---|
Comments | The two-sided 95% confidence interval (CI) of the intergroup difference (sertraline group - paroxetine group) of the mean reduction in the PAS total score at each dose during the treatment phase was calculated using an analysis of covariance (ANCOVA) model with treatment group as a factor and baseline PAS total score as a covariate. | |
Type of Statistical Test | Non-Inferiority or Equivalence (legacy) | |
Comments | Sertraline was concluded to be non-inferior to paroxetine when the upper limit of the CI fell below the non-inferiority margin of 4. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.4 | |
Confidence Interval |
(2-Sided) 95% -2.5 to 1.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement |
---|---|
Description | The ratings were rated to compare with baseline by 7-point " 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse". Responder was defined as number of participants who were assessed as "very much improved" or " much improved". |
Time Frame | 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12. Last Observation Carried Forward |
Arm/Group Title | Sertraline | Paroxetine |
---|---|---|
Arm/Group Description | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. |
Measure Participants | 127 | 127 |
Number [Percentage of participants] |
83.5
53.2%
|
85.0
52.5%
|
Title | Mean Change From Baseline in Panic Attack at the End of Treatment Phase |
---|---|
Description | Panic attacks were defined as having four or more of the following Diagnostic and Statistical Manual of Mental Disorders symptoms. Palpitations or increased heart rate, Sweating, Trembling or shaking, Shortness of breath or smothering sensations, Choking, Chest pain or discomfort, Nausea or upset stomach, Dizziness, unsteady feelings or faintness, Feeling unlike yourself, or detached from a situation and/or like things happening around you are strange and unreal, Fear of going crazy or doing something uncontrolled, Fear of dying, Abnormal sense, Hot flashes or chills. |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12. Last Observation Carried Forward |
Arm/Group Title | Sertraline | Paroxetine |
---|---|---|
Arm/Group Description | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. |
Measure Participants | 127 | 127 |
Mean (Standard Deviation) [panic attacks per week] |
-4.07
(6.12)
|
-4.59
(7.52)
|
Title | Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase |
---|---|
Description | The Hamilton Anxiety Rating Scale provided a 5-point intensity rating (0=None to 4=Very severe) of anxiety symptoms in 14 items. The increasing values are considered worse outcome. The total possible score is ranged from 0 to 52. |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12. Last Observation Carried Forward |
Arm/Group Title | Sertraline | Paroxetine |
---|---|---|
Arm/Group Description | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. |
Measure Participants | 127 | 127 |
Mean (Standard Deviation) [Scores on a scale] |
-11.35
(10.45)
|
-10.36
(8.27)
|
Title | Number of Participants With Summary of Adverse Events in Treatment Phase |
---|---|
Description | Number of sparticipants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants were counted only once per treatment in each row. |
Time Frame | 1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug |
Outcome Measure Data
Analysis Population Description |
---|
The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug. |
Arm/Group Title | Sertraline | Paroxetine |
---|---|---|
Arm/Group Description | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. |
Measure Participants | 157 | 162 |
Subjects with adverse events |
127
80.9%
|
134
82.7%
|
Subjects with serious adverse events |
1
0.6%
|
1
0.6%
|
Subjects with severe adverse events |
3
1.9%
|
14
8.6%
|
Subjects discontinued due to adverse events |
14
8.9%
|
23
14.2%
|
Dose reduced or temporary discontinuation |
13
8.3%
|
14
8.6%
|
Title | Summary of Adverse Events in Tapering Phase |
---|---|
Description | Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects were counted only once per treatment in each row. |
Time Frame | 4 weeks |
Outcome Measure Data
Analysis Population Description |
---|
The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug. |
Arm/Group Title | Sertraline | Paroxetine |
---|---|---|
Arm/Group Description | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. |
Measure Participants | 132 | 122 |
Subjects with adverse events |
73
46.5%
|
87
53.7%
|
Subjects with serious adverse events |
1
0.6%
|
0
0%
|
Subjects with severe adverse events |
11
7%
|
16
9.9%
|
Subjects discontinued due to adverse events |
1
0.6%
|
4
2.5%
|
Dose reduced or temporary discontinuation |
0
0%
|
0
0%
|
Title | Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase |
---|---|
Description | The percentage of participants divided was calcurated as follows: Devide the number of participants who had experienced new symptoms in Week 16, regardless of causal relationship with the study drug, or worsening of the severity in Week 16 compared with Week 12, by total number of participants in each treatment group. |
Time Frame | 4 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Completer Set : Subset of patients in the EES who had a PAS rating at Week 16. |
Arm/Group Title | Sertraline | Paroxetine |
---|---|---|
Arm/Group Description | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. |
Measure Participants | 124 | 118 |
Number [Percentage of participants] |
59.7
38%
|
76.3
47.1%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Sertraline, Paroxetine |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0062 |
Comments | The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05 (two-sided). | |
Method | Fisher Exact | |
Comments |
Adverse Events
Time Frame | 16 weeks | |||
---|---|---|---|---|
Adverse Event Reporting Description | The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. | |||
Arm/Group Title | Sertraline | Paroxetine | ||
Arm/Group Description | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. | ||
All Cause Mortality |
||||
Sertraline | Paroxetine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Sertraline | Paroxetine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/157 (1.3%) | 1/162 (0.6%) | ||
Infections and infestations | ||||
Enteritis infectious | 0/157 (0%) | 1/162 (0.6%) | ||
Psychiatric disorders | ||||
Suicidal ideation | 1/157 (0.6%) | 0/162 (0%) | ||
Skin and subcutaneous tissue disorders | ||||
Erythema multiforme | 1/157 (0.6%) | 0/162 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Sertraline | Paroxetine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 132/157 (84.1%) | 137/162 (84.6%) | ||
Cardiac disorders | ||||
Palpitations | 7/157 (4.5%) | 10/162 (6.2%) | ||
Tachycardia | 5/157 (3.2%) | 13/162 (8%) | ||
Ear and labyrinth disorders | ||||
Tinnitus | 1/157 (0.6%) | 10/162 (6.2%) | ||
Vertigo | 7/157 (4.5%) | 21/162 (13%) | ||
Gastrointestinal disorders | ||||
Abdominal discomfort | 7/157 (4.5%) | 6/162 (3.7%) | ||
Abdominal pain upper | 11/157 (7%) | 8/162 (4.9%) | ||
Constipation | 7/157 (4.5%) | 23/162 (14.2%) | ||
Diarrhoea | 37/157 (23.6%) | 29/162 (17.9%) | ||
Dry mouth | 15/157 (9.6%) | 10/162 (6.2%) | ||
Nausea | 43/157 (27.4%) | 66/162 (40.7%) | ||
Stomatitis | 5/157 (3.2%) | 1/162 (0.6%) | ||
Vomiting | 7/157 (4.5%) | 13/162 (8%) | ||
General disorders | ||||
Asthenia | 7/157 (4.5%) | 15/162 (9.3%) | ||
Chills | 9/157 (5.7%) | 16/162 (9.9%) | ||
Fatigue | 12/157 (7.6%) | 17/162 (10.5%) | ||
Feeling jittery | 6/157 (3.8%) | 15/162 (9.3%) | ||
Irritability | 8/157 (5.1%) | 22/162 (13.6%) | ||
Malaise | 12/157 (7.6%) | 17/162 (10.5%) | ||
Thirst | 6/157 (3.8%) | 7/162 (4.3%) | ||
Infections and infestations | ||||
Nasopharyngitis | 37/157 (23.6%) | 35/162 (21.6%) | ||
Metabolism and nutrition disorders | ||||
Decreased appetite | 6/157 (3.8%) | 9/162 (5.6%) | ||
Musculoskeletal and connective tissue disorders | ||||
Musculoskeletal stiffness | 7/157 (4.5%) | 1/162 (0.6%) | ||
Myalgia | 7/157 (4.5%) | 16/162 (9.9%) | ||
Nervous system disorders | ||||
Disturbance in attention | 9/157 (5.7%) | 19/162 (11.7%) | ||
Dizziness | 42/157 (26.8%) | 61/162 (37.7%) | ||
Headache | 20/157 (12.7%) | 47/162 (29%) | ||
Hypoaesthesia | 5/157 (3.2%) | 9/162 (5.6%) | ||
Myoclonus | 4/157 (2.5%) | 6/162 (3.7%) | ||
Paraesthesia | 4/157 (2.5%) | 11/162 (6.8%) | ||
Somnolence | 34/157 (21.7%) | 62/162 (38.3%) | ||
Tremor | 6/157 (3.8%) | 19/162 (11.7%) | ||
Psychiatric disorders | ||||
Abnormal dreams | 4/157 (2.5%) | 11/162 (6.8%) | ||
Anxiety | 16/157 (10.2%) | 24/162 (14.8%) | ||
Depression | 9/157 (5.7%) | 14/162 (8.6%) | ||
Insomnia | 19/157 (12.1%) | 30/162 (18.5%) | ||
Mood altered | 8/157 (5.1%) | 15/162 (9.3%) | ||
Panic disorder | 2/157 (1.3%) | 6/162 (3.7%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Yawning | 3/157 (1.9%) | 8/162 (4.9%) | ||
Skin and subcutaneous tissue disorders | ||||
Hyperhidrosis | 16/157 (10.2%) | 18/162 (11.1%) | ||
Urticaria | 5/157 (3.2%) | 2/162 (1.2%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title | Pfizer ClinicalTrials.gov Call Center |
---|---|
Organization | Pfizer, Inc. |
Phone | 1-800-718-1021 |
ClinicalTrials.gov_Inquiries@pfizer.com |
- A0501088