Trial · NCT00866294
Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study)
NCT00866294, Phase 3, Completed, GlaxoSmithKline; results first posted 2010-11-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study). Trials, record NCT00866294. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00866294
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study)
- NCT number
- NCT00866294
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 416 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Depressive Disorder
- Interventions
paroxetine IR 10mg tablet, paroxetine IR 20mg tablet, matched placebo to paroxetine IR 10mg or 20mg, Paroxetine CR 12.5mg tablet, Paroxetine CR 25mg tablet, matched placebo to paroxetine CR 12.5mg or 25mg
- First posted
- 2009-03-20
- Last updated
- 2017-01-30
- Results first posted
- 2010-11-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8 | Baseline (Week 0) and Week 8 | 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. |
| Secondary | Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8 | Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8 | 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. |
| Secondary | Percentage of HAM-D Responders at Weeks 4 and 8 | Weeks 4 and 8 | 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. |
| Secondary | Percentage of HAM-D Remitters at Weeks 4 and 8 | Weeks 4 and 8 | 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. |
| Secondary | Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8 | Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8 | 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. |
| Secondary | Percentage of Responders Based on the Clinical Global Impression-Global Improvement (CGI-GI) Scores at Weeks 4 and 8 | Weeks 4 and 8 | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8 | Baseline (Week 0) and Week 8 | 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. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8 | Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8 | 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. | scores on a scale | MEAN |
| SECONDARY | Percentage of HAM-D Responders at Weeks 4 and 8 | Weeks 4 and 8 | 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. | percentage of responders | NUMBER |
| SECONDARY | Percentage of HAM-D Remitters at Weeks 4 and 8 | Weeks 4 and 8 | 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. | percentage of remitters | NUMBER |
| SECONDARY | Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8 | Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8 | 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. | scores on a scale | MEAN |
| SECONDARY | Percentage of Responders Based on the Clinical Global Impression-Global Improvement (CGI-GI) Scores at Weeks 4 and 8 | Weeks 4 and 8 | 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. | percentage of responders | NUMBER |
Source ClinicalTrials.gov
Results by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8 | Placebo | -10.4 | Standard Error 0.62 | scores on a scale | |
| Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8 | Paroxetine CR | -12.8 | Standard Error 0.61 | scores on a scale | |
| Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8 | Paroxetine IR | -12.5 | Standard Error 0.78 | scores on a scale | |
| Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8 | Placebo | Week 1, n=171, 157, 83 | -3.1 | Standard Deviation 4.04 | scores on a scale |
| Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8 | Paroxetine CR | Week 1, n=171, 157, 83 | -2.9 | Standard Deviation 4.05 | scores on a scale |
| Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8 | Paroxetine IR | Week 1, n=171, 157, 83 | -3.5 | Standard Deviation 4.36 | scores on a scale |
| Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8 | Placebo | Week 2, n=171, 158, 83 | -5.2 | Standard Deviation 5.11 | scores on a scale |
| Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8 | Paroxetine CR | Week 2, n=171, 158, 83 | -5.5 | Standard Deviation 4.85 | scores on a scale |
| Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8 | Paroxetine IR | Week 2, n=171, 158, 83 | -6.2 | Standard Deviation 4.93 | scores on a scale |
| Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8 | Placebo | Week 3, n=171, 158, 83 | -6.7 | Standard Deviation 6.05 | scores on a scale |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 172 | |
| Overall Study | STARTED | Paroxetine CR | 161 | |
| Overall Study | STARTED | Paroxetine IR | 83 | |
| Overall Study | COMPLETED | Placebo | 139 | |
| Overall Study | COMPLETED | Paroxetine CR | 141 | |
| Overall Study | COMPLETED | Paroxetine IR | 72 | |
| Overall Study | NOT COMPLETED | Placebo | 33 | |
| Overall Study | NOT COMPLETED | Paroxetine CR | 20 | |
| Overall Study | NOT COMPLETED | Paroxetine IR | 11 |
Source ClinicalTrials.gov
Adverse events154
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 14 | 172 | |
| other | Nausea | Gastrointestinal disorders | Paroxetine CR 12.5-50 mg/Day | 8 | 79 | |
| other | Nausea | Gastrointestinal disorders | Paroxetine CR 25-50 mg/Day | 21 | 82 | |
| other | Nausea | Gastrointestinal disorders | Paroxetine CR, Total | 29 | 161 | |
| other | Nausea | Gastrointestinal disorders | Paroxetine IR 10-40 mg/Day | 8 | 43 | |
| other | Nausea | Gastrointestinal disorders | Paroxetine IR 20-40 mg/Day | 8 | 40 | |
| other | Nausea | Gastrointestinal disorders | Paroxetine IR, Total | 16 | 83 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 5 | 172 | |
| other | Constipation | Gastrointestinal disorders | Paroxetine CR 12.5-50 mg/Day | 9 | 79 | |
| other | Constipation | Gastrointestinal disorders | Paroxetine CR 25-50 mg/Day | 8 | 82 |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Paroxetine CR 12.5-50 mg/Day | ||
| Total, all-cause mortality | Paroxetine CR 25-50 mg/Day | ||
| Total, all-cause mortality | Paroxetine CR, Total | ||
| Total, all-cause mortality | Paroxetine IR 10-40 mg/Day | ||
| Total, all-cause mortality | Paroxetine IR 20-40 mg/Day | ||
| Total, all-cause mortality | Paroxetine IR, Total | ||
| Total, other adverse events | Placebo | 76 | 172 |
| Total, other adverse events | Paroxetine CR 12.5-50 mg/Day | 43 | 79 |
| Total, other adverse events | Paroxetine CR 25-50 mg/Day | 50 | 82 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21895859 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00866294
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