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Trial record 38 of 1295 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND weeks

Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study)

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ClinicalTrials.gov Identifier: NCT00866294
Recruitment Status : Completed
First Posted : March 20, 2009
Results First Posted : November 15, 2010
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depressive Disorder
Interventions Drug: paroxetine IR 10mg tablet
Drug: paroxetine IR 20mg tablet
Drug: matched placebo to paroxetine IR 10mg or 20mg
Drug: Paroxetine CR 12.5mg tablet
Drug: Paroxetine CR 25mg tablet
Drug: matched placebo to paroxetine CR 12.5mg or 25mg
Enrollment 416
Recruitment Details  
Pre-assignment Details Participants who had completed all the study procedures (up to the post-study examinations) were defined as per protocol completers.
Arm/Group Title Placebo Paroxetine CR Paroxetine IR
Hide Arm/Group Description Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks). An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment. An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
Period Title: Overall Study
Started 172 161 83
Completed 139 141 72
Not Completed 33 20 11
Reason Not Completed
Adverse Event             12             13             9
Lack of Efficacy             7             1             0
Protocol Violation             2             0             0
Met Protocol-defined Stopping Criteria             5             1             1
Lost to Follow-up             1             3             0
Physician Decision             6             2             1
Arm/Group Title Placebo Paroxetine CR Paroxetine IR Total
Hide Arm/Group Description Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks). An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment. An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment. Total of all reporting groups
Overall Number of Baseline Participants 172 161 83 416
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 172 participants 161 participants 83 participants 416 participants
36.8  (10.04) 36.4  (11.36) 35.5  (10.38) 36.4  (10.62)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants 161 participants 83 participants 416 participants
Female
94
  54.7%
86
  53.4%
48
  57.8%
228
  54.8%
Male
78
  45.3%
75
  46.6%
35
  42.2%
188
  45.2%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 172 participants 161 participants 83 participants 416 participants
Asian - East Asian Heritage 17 20 10 47
Asian - Japanese Heritage 154 138 73 365
[1]
Measure Description: The number of participants is based on the Full Analysis Set (FAS), consisting of all participants who entered the treatment phase, excluding those who had taken no dose of the investigational product for the treatment phase and those who had no data on the Hamilton Depression Rating Scale (HAM-D) total score after the start of the treatment phase.
1.Primary Outcome
Title Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8
Hide Description The HAM-D measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at Week 8 minus the Baseline value.
Time Frame Baseline (Week 0) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who entered the treatment phase (8 weeks), excluding those who had taken no dose of the investigational product for the treatment phase and who had no data on the HAM-D total score after the start of the treatment phase. The analysis was performed on the last observation carried forward (LOCF) dataset.
Arm/Group Title Placebo Paroxetine CR Paroxetine IR
Hide Arm/Group Description:
Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily.
An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
Overall Number of Participants Analyzed 171 158 83
Mean (Standard Error)
Unit of Measure: scores on a scale
-10.4  (0.62) -12.8  (0.61) -12.5  (0.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Paroxetine CR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The hypothesis test was conducted with a two-sided significance level of 5% to show the superiority of paroxetine CR relative to placebo.
Method ANCOVA
Comments The primary analysis was based on an ANCOVA with a model adjusting for baseline HAM-D total score and region (Japan and South Korea).
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-3.8 to -1.1
Estimation Comments Mean difference = paroxetine CR minus placebo
2.Secondary Outcome
Title Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8
Hide Description The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at each time point minus the Baseline value.
Time Frame Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The analysis was performed on the following datasets: the observed case (OC) dataset for Week 1 and the LOCF dataset for Weeks 2, 3, 4, 6, and 8, where missing values were imputed by the last observed value in the longitudinal data. One participant in the Paroxetine CR group was not included in the OC analysis for having a missing value.
Arm/Group Title Placebo Paroxetine CR Paroxetine IR
Hide Arm/Group Description:
Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
Overall Number of Participants Analyzed 171 158 83
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=171, 157, 83 -3.1  (4.04) -2.9  (4.05) -3.5  (4.36)
Week 2, n=171, 158, 83 -5.2  (5.11) -5.5  (4.85) -6.2  (4.93)
Week 3, n=171, 158, 83 -6.7  (6.05) -7.5  (5.64) -7.3  (4.70)
Week 4, n=171, 158, 83 -8.0  (6.10) -9.3  (5.66) -9.1  (5.66)
Week 6, n=171, 158, 83 -8.8  (6.40) -10.9  (6.21) -10.4  (5.78)
Week 8, n=171, 158, 83 -9.8  (6.68) -12.4  (6.41) -12.0  (5.83)
3.Secondary Outcome
Title Percentage of HAM-D Responders at Weeks 4 and 8
Hide Description The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is a sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Responders are defined as participants with a 50 percent or greater reduction from baseline in the HAM-D total score.
Time Frame Weeks 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they were withdrawn prematurely.
Arm/Group Title Placebo Paroxetine CR Paroxetine IR
Hide Arm/Group Description:
Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
Overall Number of Participants Analyzed 171 158 83
Measure Type: Number
Unit of Measure: percentage of responders
Week 4, n=158, 154, 78 30 40 40
Week 8 (OC), n=144, 145, 74 52 66 59
Week 8 LOCF, n=171, 158, 83 46 63 57
4.Secondary Outcome
Title Percentage of HAM-D Remitters at Weeks 4 and 8
Hide Description The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Remitters are defined as participants with a HAM-D total score of 7 or less.
Time Frame Weeks 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they were withdrawn prematurely.
Arm/Group Title Placebo Paroxetine CR Paroxetine IR
Hide Arm/Group Description:
Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
Overall Number of Participants Analyzed 171 158 83
Measure Type: Number
Unit of Measure: percentage of remitters
Week 4, n=158, 154, 78 16 15 18
Week 8 (OC), n=144, 145, 74 26 38 39
Week 8 LOCF, n=171, 158, 83 23 35 36
5.Secondary Outcome
Title Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8
Hide Description The 7-point CGI-SI scale assesses the clinician’s impression of the participant's current illness state. Scores on the CGI-SI range from 1 = not ill at all to 7 = among the most extremely ill. Mean change from baseline was calculated as the value at each time point minus the baseline value.
Time Frame Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they had missing values or they were withdrawn prematurely.
Arm/Group Title Placebo Paroxetine CR Paroxetine IR
Hide Arm/Group Description:
Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
Overall Number of Participants Analyzed 171 158 83
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=171, 157, 83 -0.1  (0.46) -0.2  (0.43) -0.2  (0.58)
Week 2, n=164, 155, 80 -0.4  (0.68) -0.4  (0.59) -0.5  (0.67)
Week 3, n=161, 155, 78 -0.6  (0.83) -0.7  (0.74) -0.6  (0.72)
Week 4, n=158, 153, 79 -0.7  (0.85) -0.8  (0.85) -0.8  (0.93)
Week 6, n=151, 147, 76 -0.9  (0.87) -1.1  (0.98) -0.9  (0.90)
Week 8, n=144, 145, 74 -1.0  (0.96) -1.3  (1.02) -1.3  (1.01)
Week 8 LOCF, n=171, 158, 83 -0.9  (1.02) -1.2  (1.02) -1.1  (1.05)
6.Secondary Outcome
Title Percentage of Responders Based on the Clinical Global Impression-Global Improvement (CGI-GI) Scores at Weeks 4 and 8
Hide Description The 7-point CGI-GI assesses the participant's improvement or worsening from baseline. Scores on the CGI-GI range from 1 = very much improved to 7 = very much worse. Responders are defined as participants with a score of 1 or 2 = much improved.
Time Frame Weeks 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they had missing values or they were withdrawn prematurely.
Arm/Group Title Placebo Paroxetine CR Paroxetine IR
Hide Arm/Group Description:
Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
Overall Number of Participants Analyzed 171 158 83
Measure Type: Number
Unit of Measure: percentage of responders
Week 4, n=158, 153, 79 40 51 56
Week 8 (OC), n=144, 145, 74 60 76 78
Week 8 LOCF, n=171, 158, 83 53 71 75
Time Frame AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Paroxetine CR 12.5-50 mg/Day Paroxetine CR 25-50 mg/Day Paroxetine CR, Total Paroxetine IR 10-40 mg/Day Paroxetine IR 20-40 mg/Day Paroxetine IR, Total
Hide Arm/Group Description Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks). An initial dose of 12.5 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 25 mg/day, and 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment. An initial dose of 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment. All participants receiving either paroxetine CR 12.5-50 mg/day or 25-50 mg/day An initial dose of 10 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 20 mg/day, and 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment. An initial dose of 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment. All participants receiving either paroxetine IR 10-40 mg/day or 20-40 mg/day
All-Cause Mortality
Placebo Paroxetine CR 12.5-50 mg/Day Paroxetine CR 25-50 mg/Day Paroxetine CR, Total Paroxetine IR 10-40 mg/Day Paroxetine IR 20-40 mg/Day Paroxetine IR, Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Paroxetine CR 12.5-50 mg/Day Paroxetine CR 25-50 mg/Day Paroxetine CR, Total Paroxetine IR 10-40 mg/Day Paroxetine IR 20-40 mg/Day Paroxetine IR, Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/172 (0.58%)   2/79 (2.53%)   4/82 (4.88%)   6/161 (3.73%)   2/43 (4.65%)   0/40 (0.00%)   2/83 (2.41%) 
Injury, poisoning and procedural complications               
Drug toxicity  1  0/172 (0.00%)  0/79 (0.00%)  0/82 (0.00%)  0/161 (0.00%)  1/43 (2.33%)  0/40 (0.00%)  1/83 (1.20%) 
Rib fracture  1  1/172 (0.58%)  0/79 (0.00%)  0/82 (0.00%)  0/161 (0.00%)  0/43 (0.00%)  0/40 (0.00%)  0/83 (0.00%) 
Metabolism and nutrition disorders               
Decreased appetite  1  0/172 (0.00%)  0/79 (0.00%)  1/82 (1.22%)  1/161 (0.62%)  0/43 (0.00%)  0/40 (0.00%)  0/83 (0.00%) 
Musculoskeletal and connective tissue disorders               
Back pain  1  0/172 (0.00%)  0/79 (0.00%)  1/82 (1.22%)  1/161 (0.62%)  0/43 (0.00%)  0/40 (0.00%)  0/83 (0.00%) 
Nervous system disorders               
Dizziness  1  0/172 (0.00%)  1/79 (1.27%)  0/82 (0.00%)  1/161 (0.62%)  0/43 (0.00%)  0/40 (0.00%)  0/83 (0.00%) 
Headache  1  0/172 (0.00%)  0/79 (0.00%)  1/82 (1.22%)  1/161 (0.62%)  0/43 (0.00%)  0/40 (0.00%)  0/83 (0.00%) 
Psychiatric disorders               
Alcohol abuse  1  0/172 (0.00%)  1/79 (1.27%)  0/82 (0.00%)  1/161 (0.62%)  0/43 (0.00%)  0/40 (0.00%)  0/83 (0.00%) 
Conversion disorder  1  0/172 (0.00%)  0/79 (0.00%)  0/82 (0.00%)  0/161 (0.00%)  1/43 (2.33%)  0/40 (0.00%)  1/83 (1.20%) 
Major depression  1  0/172 (0.00%)  0/79 (0.00%)  1/82 (1.22%)  1/161 (0.62%)  0/43 (0.00%)  0/40 (0.00%)  0/83 (0.00%) 
Suicide attempt  1  0/172 (0.00%)  0/79 (0.00%)  1/82 (1.22%)  1/161 (0.62%)  0/43 (0.00%)  0/40 (0.00%)  0/83 (0.00%) 
Completed suicide  1  0/172 (0.00%)  0/79 (0.00%)  0/82 (0.00%)  0/161 (0.00%)  1/43 (2.33%)  0/40 (0.00%)  1/83 (1.20%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Paroxetine CR 12.5-50 mg/Day Paroxetine CR 25-50 mg/Day Paroxetine CR, Total Paroxetine IR 10-40 mg/Day Paroxetine IR 20-40 mg/Day Paroxetine IR, Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   76/172 (44.19%)   43/79 (54.43%)   50/82 (60.98%)   93/161 (57.76%)   23/43 (53.49%)   21/40 (52.50%)   44/83 (53.01%) 
Gastrointestinal disorders               
Nausea  1  14/172 (8.14%)  8/79 (10.13%)  21/82 (25.61%)  29/161 (18.01%)  8/43 (18.60%)  8/40 (20.00%)  16/83 (19.28%) 
Constipation  1  5/172 (2.91%)  9/79 (11.39%)  8/82 (9.76%)  17/161 (10.56%)  4/43 (9.30%)  3/40 (7.50%)  7/83 (8.43%) 
Diarrhoea  1  8/172 (4.65%)  1/79 (1.27%)  6/82 (7.32%)  7/161 (4.35%)  4/43 (9.30%)  4/40 (10.00%)  8/83 (9.64%) 
Dry mouth  1  7/172 (4.07%)  3/79 (3.80%)  4/82 (4.88%)  7/161 (4.35%)  2/43 (4.65%)  3/40 (7.50%)  5/83 (6.02%) 
Infections and infestations               
Nasopharyngitis  1  33/172 (19.19%)  8/79 (10.13%)  13/82 (15.85%)  21/161 (13.04%)  4/43 (9.30%)  4/40 (10.00%)  8/83 (9.64%) 
Nervous system disorders               
Headache  1  18/172 (10.47%)  5/79 (6.33%)  7/82 (8.54%)  12/161 (7.45%)  2/43 (4.65%)  2/40 (5.00%)  4/83 (4.82%) 
Somnolence  1  4/172 (2.33%)  11/79 (13.92%)  5/82 (6.10%)  16/161 (9.94%)  4/43 (9.30%)  3/40 (7.50%)  7/83 (8.43%) 
Dizziness  1  4/172 (2.33%)  5/79 (6.33%)  6/82 (7.32%)  11/161 (6.83%)  3/43 (6.98%)  1/40 (2.50%)  4/83 (4.82%) 
Tremor  1  0/172 (0.00%)  3/79 (3.80%)  1/82 (1.22%)  4/161 (2.48%)  2/43 (4.65%)  3/40 (7.50%)  5/83 (6.02%) 
Psychiatric disorders               
Withdrawal syndrome  1  10/172 (5.81%)  12/79 (15.19%)  17/82 (20.73%)  29/161 (18.01%)  3/43 (6.98%)  2/40 (5.00%)  5/83 (6.02%) 
Renal and urinary disorders               
Pollakiuria  1  3/172 (1.74%)  1/79 (1.27%)  1/82 (1.22%)  2/161 (1.24%)  2/43 (4.65%)  3/40 (7.50%)  5/83 (6.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00866294     History of Changes
Other Study ID Numbers: 112810
First Submitted: March 19, 2009
First Posted: March 20, 2009
Results First Submitted: October 14, 2010
Results First Posted: November 15, 2010
Last Update Posted: January 30, 2017