Trial · NCT00812812
Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study)
NCT00812812, Phase 4, Terminated, GlaxoSmithKline; results first posted 2011-10-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study). Trials, record NCT00812812. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00812812
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study)
- NCT number
- NCT00812812
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 56 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Depressive Disorder
- Interventions
- paroxetine 10mg tablet, paroxetine 20mg tablet, matched placebo to paroxetine 10mg, matched placebo to paroxetine 20mg
- First posted
- 2008-12-22
- Last updated
- 2017-01-13
- Results first posted
- 2011-10-13
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8 | Baseline and Week 8 | The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression). CDRS-R scores were assessed by the investigator. The change from Baseline in the CDRS-R total score was calculated as the total score at Week 8 minus the total score at Baseline. The data were adjusted with the total score at Baseline. |
| Secondary | Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6 | Baseline and Weeks 1, 2, 3, 4, and 6 | The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression). CDRS-R scores were assessed by the investigator. The change from Baseline in the CDRS-R total score was calculated as the total score at Week 8 minus the total score at Baseline. The data were adjusted with the total score at Baseline. |
| Secondary | Number of Clinical Global Impression - Global Improvement (CGI-GI) Responders at Weeks 1, 2, 3, 4, 6, and 8 | Weeks 1, 2, 3, 4, 6, and 8 | CGI-GI is assessed on an 8-grade scale: 0, not assessed; 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse. CGI-GI was assessed by the investigator. Participants who were rated as 1 (very much improved) or 2 (much improved) were categorized as CGI-GI responders. |
| Secondary | Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-SI) Score at Weeks 1, 2, 3, 4, 6, and 8 | Baseline and Weeks 1, 2, 3, 4, 6, and 8 | CGI-SI is assessed on an 8-grade scale: 0, not assessed; 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; and 7, among the most extremely ill. CGI-SI was assessed by the investigator. The change from Baseline in CGI-SI score was calculated as the score at Weeks 1, 2, 3, 4, 6, and 8 minus the score at Baseline. |
| Secondary | Plasma Paroxetine Concentrations at 12 Hours and 24 Hours After Administration of Study Drug at Week 8 or Withdrawal | Week 8 or Withdrawal (up to Week 8) | Summary statistics for the plasma paroxetine concentrations at each time point were calculated by the dosage just before blood sampling using data from participants in whom plasma samples were collected at either 12 hours (plus or minus 2 hours) or 24 hours (plus or minus 2 hours) after the last administration of the study drug at Week 8 or Withdrawal (up to Week 8). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8 | Baseline and Week 8 | Full Analysis Set (FAS): all participants who entered the treatment phase, but excluding participants without the target indication, participants who received no tablet of the treatment phase medication, or participants who had no post-baseline CDRS-R data. The analysis was performed on the last observation carried forward (LOCF) dataset. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6 | Baseline and Weeks 1, 2, 3, 4, and 6 | FAS. The analysis was performed on the observed case (OC) dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Clinical Global Impression - Global Improvement (CGI-GI) Responders at Weeks 1, 2, 3, 4, 6, and 8 | Weeks 1, 2, 3, 4, 6, and 8 | FAS. The analysis was performed on the OC dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week. The analysis of data at Week 8 was also performed on the LOCF dataset. | participants | NUMBER |
| SECONDARY | Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-SI) Score at Weeks 1, 2, 3, 4, 6, and 8 | Baseline and Weeks 1, 2, 3, 4, 6, and 8 | FAS. The analysis was performed on the OC dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week. The analysis of data at Week 8 was also performed on the LOCF dataset. | scores on a scale | MEAN |
| SECONDARY | Plasma Paroxetine Concentrations at 12 Hours and 24 Hours After Administration of Study Drug at Week 8 or Withdrawal | Week 8 or Withdrawal (up to Week 8) | All participants who received paroxetine and in whom plasma samples were collected at either 12 hours (plus or minus 2 hours) or 24 hours (plus or minus 2 hours) after the last administration of the study drug at Week 8 or Withdrawal (up to Week 8). | nanograms per milliliter (ng/mL) | MEAN |
Source ClinicalTrials.gov
Results by group47
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8 | Placebo | -11.9 | Standard Error 2.54 | scores on a scale | |
| Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8 | Paroxetine | -16.5 | Standard Error 2.45 | scores on a scale | |
| Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6 | Placebo | Week 1, n=27, 29 | -4.6 | Standard Error 1.10 | scores on a scale |
| Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6 | Paroxetine | Week 1, n=27, 29 | -5.4 | Standard Error 1.06 | scores on a scale |
| Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6 | Placebo | Week 2, n=26, 29 | -4.9 | Standard Error 1.56 | scores on a scale |
| Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6 | Paroxetine | Week 2, n=26, 29 | -8.8 | Standard Error 1.48 | scores on a scale |
| Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6 | Placebo | Week 3, n=24, 28 | -10.6 | Standard Error 1.90 | scores on a scale |
| Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6 | Paroxetine | Week 3, n=24, 28 | -12.0 | Standard Error 1.76 | scores on a scale |
| Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6 | Placebo | Week 4, n=25, 27 | -12.5 | Standard Error 2.24 | scores on a scale |
| Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6 | Paroxetine | Week 4, n=25, 27 | -14.6 | Standard Error 2.15 | scores on a scale |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 27 | |
| Overall Study | STARTED | Paroxetine | 29 | |
| Overall Study | COMPLETED | Placebo | 24 | |
| Overall Study | COMPLETED | Paroxetine | 25 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Paroxetine | 4 |
Source ClinicalTrials.gov
Adverse events10
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 | Nasopharyngitis | Infections and infestations | Placebo | 4 | 27 | |
| other | Nasopharyngitis | Infections and infestations | Paroxetine | 6 | 29 | |
| other | Influenza | Infections and infestations | Placebo | 2 | 27 | |
| other | Influenza | Infections and infestations | Paroxetine | 1 | 29 | |
| other | Suicidal ideation | Psychiatric disorders | Placebo | 3 | 27 | |
| other | Suicidal ideation | Psychiatric disorders | Paroxetine | 0 | 29 | |
| other | Dysmenorrhoea | Reproductive system and breast disorders | Placebo | 2 | 27 | |
| other | Dysmenorrhoea | Reproductive system and breast disorders | Paroxetine | 1 | 29 | |
| other | Headache | Nervous system disorders | Placebo | 0 | 27 | |
| other | Headache | Nervous system disorders | Paroxetine | 2 | 29 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Paroxetine | ||
| Total, other adverse events | Placebo | 9 | 27 |
| Total, other adverse events | Paroxetine | 9 | 29 |
| Total, serious adverse events | Placebo | 0 | 27 |
| Total, serious adverse events | Paroxetine | 0 | 29 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Paroxetine vs Placebo: serious adverse events |
Source Trial comparisons
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00812812
GET https://conductscience.org/api/trials/v1/NCT00812812/results?page=2