Depressive DisorderPhase 4NCT00812812

Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study)

A Phase 4 study testing paroxetine 10mg tablet and paroxetine 20mg tablet in people with Depressive Disorder, run by GlaxoSmithKline at 33 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study is designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with major depressive disorder (MDD) based on the change from baseline to Week 8/end-of-study in the CDRS-R… Read more about this study

Who is it for?: Ages 7 to 17 years
Conditions the study is for: Depressive Disorder
What is being tested?: paroxetine 10mg tablet and paroxetine 20mg tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 33 sitesJapan
Study dates: Mar 2009to Feb 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

run-in period: A subject will be considered eligible for the study only if all of the following criteria apply at start of placebo run-in period.
Patients who are diagnosed with the following depressive disorders according to the DSM-IV-TR criteria, and currently presents with a depressive episodes. Depressive disorders: MDD, single episode (296.2), MDD, recurrent (296.3)
7 years and older and under 18 years old (at the time of consent obtained)
Patients with a total raw summary score on the CDRS-R of 45 or greater at the Week -2 visit.
Patients whose legally acceptable representative (e.g., caretaker, custodian) is able to give written consent to participation to this study. Patients aged 12 and above at the time of consent obtained should be able to sign the informed consent on one's own. Efforts should be exerted in obtaining the informed assent in writing from patients aged less than 12.
Patients with ideal body weight +/- 2SD

Show all 10Show fewer

Gender: Male or female
treatment period:
Subjects who meet the following criteria at Week 0 (Baseline) may be progressed to the Treatment period:
Patients with a total raw summary score on the CDRS-R at Week 0 visit of 45 or greater.

Who cannot join

run-in period:
A subject will not be eligible for inclusion to this study if any of the following criteria applies at start of run-in period:
Patients who in the investigator's judgment presented with a clinically predominant Axis I disorder other than MDD (e.g. dysthymic disorder, eating disorders, Specific phobia, PTSD, OCD, Panic disorder, etc)
Patients with any history of a psychotic episode or psychotic disorder (including schizophrenia ), or complication of these diseases.
Patients with a history of a bipolar disorder, or complication of these diseases.
Patients with Attention-Deficit, or Hyperactivity Disorder

Show all 30Show fewer

Patients with Mental Retardation or Pervasive Development Disorder
Patients diagnosed with Substance Abuse or Dependence within 12 weeks prior to the Screening visit
Patients with past treatment experience with the investigational drug (i.e. paroxetine)
Patients treated with electroconvulsive therapy in the immediate 12 weeks prior to the Screening visit
Patients with past history of serotonin syndrome and neuroleptic malignant syndrome.
Patients with CDRS-R score of "suicidal ideation" of 3 or greater. Or patients whose C-SSRS assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the chief investigator (subinvestigator), are at significant risk for harming self.
Patients with past history of suicide attempt, self harm(excluding "no suicidal intent " ), or an intentional overdose (excluding obviously unintentional overdose)
Patients who have been treated with other clinical trial investigational drug (including post-marketing clinical trial) in the immediate past 3 months of the Week -2 visit.
Patients who have taken antidepressant medication 1 week prior to screening.
Patients with complicated disease of glaucoma.
Patients with convulsive disorders such as epilepsy or past history of these diseases.
Patients regularly using drugs (e.g. NSAIDs) that would increase the risk of haemorrhage, or patients with bleeding tendency or haemorrhagic diathesis.
Patients with severe renal and hepatic disorder.
Patients with serious organic disorder in the brain.
Patients with chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody.
Patients with a current history of carcinoma or malignant tumor, or complication of these diseases.
Female patients who are pregnant, lactating, or who might be pregnant, or who wish to be pregnant during the study period
Patients in the opinion of the chief investigator (subinvestigator) judged as not eligible for the study.
Patients with clinical significant comorbid impulsivity symptoms.(e.g. Personality Disorder, Conduct Disorder)
treatment period: Subjects for whom any of the following categories apply at Week 0 (start of the treatment period) will not be progressed to the treatment phase.
Patients with CDRS-R score of "suicidal ideation" of 3 or greater, or patients who, in the opinion of the chief investigator (sub investigator), are at significant risk for harming self
Patients with variation of the CDRS-R total raw summary score at Week 0 of +/-25% or greater compared to that of Week -2.
Patients with drug compliance of Drug 1 (run-in placebo) from Week -2 to Week 0 less than 80%.
Patients, in the opinion of the chief investigator (sub investigator) judged as not appropriate for the study.

Trial locations and contacts

33 sites in 1 country.

City, postcode or hospital

33 sites in 1 country

Japan33 sites

GSK Investigational Site
Aichi, 445-0064
GSK Investigational Site
Aichi, 453-0015
GSK Investigational Site
Aichi, 474-8710
GSK Investigational Site
Aichi, 479-0837
GSK Investigational Site
Fukui, 910-1193
GSK Investigational Site
Fukuoka, 800-0207
GSK Investigational Site
Fukuoka, 802-0064
GSK Investigational Site
Fukuoka, 810-0001
GSK Investigational Site
Fukuoka, 836-0004
GSK Investigational Site
Hokkaido, 002-8029
GSK Investigational Site
Hyōgo, 653-0841
GSK Investigational Site
Hyōgo, 661-0002
GSK Investigational Site
Hyōgo, 673-8501
GSK Investigational Site
Ishikawa, 921-8163
GSK Investigational Site
Kagawa, 765-8501
GSK Investigational Site
Kanagawa, 210-0006
GSK Investigational Site
Kanagawa, 220-0004
GSK Investigational Site
Kanagawa, 244-0816
GSK Investigational Site
Kumamoto, 860-8556
GSK Investigational Site
Kumamoto, 861-8002
GSK Investigational Site
Kumamoto, 862-0920
GSK Investigational Site
Nagano, 390-8510
GSK Investigational Site
Nara, 631-0036
GSK Investigational Site
Nara, 634-8522
GSK Investigational Site
Okayama, 710-0057
GSK Investigational Site
Osaka, 534-0021
GSK Investigational Site
Osaka, 545-8586
GSK Investigational Site
Osaka, 560-0082
GSK Investigational Site
Osaka, 596-0076
GSK Investigational Site
Shizuoka, 410-2295
GSK Investigational Site
Tokushima, 770-8076
GSK Investigational Site
Tokyo, 107-0052
GSK Investigational Site
Tokyo, 107-0062

Other trials in Japan

About this study

Official title: A Randomised, Double-blind, Placebo Controlled, Parallel Group , Flexible Dose Study to Evaluate the Efficacy and Safety of Paxil® Tablets in Children and Adolescents With Major Depressive Disorder<Post-marketing Clinical Study>

Conditions: Depressive Disorder
Being tested: paroxetine 10mg tablet, paroxetine 20mg tablet, matched placebo to paroxetine 10mg, matched placebo to paroxetine 20mg
Keywords: paroxetine, selective serotonin reuptake inhibitor, CDRS-R, children and adolescents
Medical subject headings: Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

paroxetine 10mg tabletDrug
Also called Paxil
1 or 2 tablet(s) once a day
paroxetine 20mg tabletDrug
Also called Paxil
1 tablet once a day
matched placebo to paroxetine 10mgDrug
2 tablets once a day
matched placebo to paroxetine 20mgDrug
1 tablet once a day

Study groups in NCT00812812
Study group	Role	What they receive
paroxetine group	Experimental	paroxetine 10-40mg/day Receives: Drug: paroxetine 10mg tablet; Drug: paroxetine 20mg tablet; Drug: matched placebo to paroxetine 10mg; Drug: matched placebo to paroxetine 20mg
placebo group	Placebo comparator	matched placebo to paroxetine Receives: Drug: matched placebo to paroxetine 10mg; Drug: matched placebo to paroxetine 20mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at 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.
Measured: Baseline and Week 8

Secondary outcomes (4)

Change From Baseline in the CDRS-R Total Score at 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.
Measured: Baseline and Weeks 1, 2, 3, 4, and 6
Number of Clinical Global Impression - Global Improvement (CGI-GI) Responders at 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.
Measured: Weeks 1, 2, 3, 4, 6, and 8
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-SI) Score at 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.
Measured: Baseline and Weeks 1, 2, 3, 4, 6, and 8
Plasma Paroxetine Concentrations at 12 Hours and 24 Hours After Administration of Study Drug at Week 8 or Withdrawal
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).
Measured: Week 8 or Withdrawal (up to Week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Feb 2011

First posted22 Dec 2008 (estimated)
Study startMar 2009
Primary completionFeb 2011
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Depressive DisorderStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00812812
Sponsor's protocol ID: 112487
Status last verified: Nov 2016
First submitted: 18 Dec 2008
Last updated: 13 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary with a conclusion.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo Controlled, Parallel Group , Flexible Dose Study to Evaluate the Efficacy and Safety of Paxil® Tablets in Children and Adolescents With Major Depressive Disorder<Post-marketing Clinical Study>
ClinicalTrials.gov ID: NCT00812812
Acronym / sponsor ID: 112487
Conditions: Depressive Disorder
Keywords: paroxetine, selective serotonin reuptake inhibitor, CDRS-R, children and adolescents
Phase: Phase 4
Study type: Interventional
Recruitment status: Terminated
Enrolment: 56 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 22 Dec 2008 (estimated)
Results: Posted 13 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
paroxetine group	Experimental	Drug: paroxetine 10mg tablet, Drug: paroxetine 20mg tablet, Drug: matched placebo to paroxetine 10mg, Drug: matched placebo to paroxetine 20mgparoxetine 10-40mg/day
placebo group	Placebo comparator	Drug: matched placebo to paroxetine 10mg, Drug: matched placebo to paroxetine 20mgmatched placebo to paroxetine

Who may qualify

Ages: 7 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (10 listed)

run-in period: A subject will be considered eligible for the study only if all of the following criteria apply at start of placebo run-in period.
Patients who are diagnosed with the following depressive disorders according to the DSM-IV-TR criteria, and currently presents with a depressive episodes. Depressive disorders: MDD, single episode (296.2), MDD, recurrent (296.3)
7 years and older and under 18 years old (at the time of consent obtained)
Patients with a total raw summary score on the CDRS-R of 45 or greater at the Week -2 visit.
Patients whose legally acceptable representative (e.g., caretaker, custodian) is able to give written consent to participation to this study. Patients aged 12 and above at the time of consent obtained should be able to sign the informed consent on one's own. Efforts should be exerted in obtaining the informed assent in writing from patients aged less than 12.

Key exclusion criteria (30 listed)

A subject will not be eligible for inclusion to this study if any of the following criteria applies at start of run-in period:
Patients who in the investigator's judgment presented with a clinically predominant Axis I disorder other than MDD (e.g. dysthymic disorder, eating disorders, Specific phobia, PTSD, OCD, Panic disorder, etc)
Patients with any history of a psychotic episode or psychotic disorder (including schizophrenia ), or complication of these diseases.
Patients with a history of a bipolar disorder, or complication of these diseases.
Patients with Attention-Deficit, or Hyperactivity Disorder

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
paroxetine 10mg tabletAlso: Paxil1 or 2 tablet(s) once a day	Drug	paroxetine group
paroxetine 20mg tabletAlso: Paxil1 tablet once a day	Drug	paroxetine group
matched placebo to paroxetine 10mg2 tablets once a day	Drug	paroxetine group, placebo group
matched placebo to paroxetine 20mg1 tablet once a day	Drug	paroxetine group, placebo group

Primary outcome

Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8
Time frame: 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.

4 secondary outcomes

Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6
Time frame: Baseline and Weeks 1, 2, 3, 4, and 6
Number of Clinical Global Impression - Global Improvement (CGI-GI) Responders at Weeks 1, 2, 3, 4, 6, and 8
Time frame: Weeks 1, 2, 3, 4, 6, and 8
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-SI) Score at Weeks 1, 2, 3, 4, 6, and 8
Time frame: Baseline and Weeks 1, 2, 3, 4, 6, and 8
Plasma Paroxetine Concentrations at 12 Hours and 24 Hours After Administration of Study Drug at Week 8 or Withdrawal
Time frame: Week 8 or Withdrawal (up to Week 8)

Results and safety

Results posted to the registry on 13 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	27	24
Paroxetine	29	25

Primary outcome: Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8

Time frame: Baseline and Week 8. Least squares mean (Standard Error). Unit: scores on a scale

Measure	Placebo n = 27	Paroxetine n = 29
Value	-11.9 (2.54)	-16.5 (2.45)

Placebo vs Paroxetine: Mean Difference (Net): -4.6 (95% CI -11.7 to 2.5), p = 0.198, ANCOVA

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) and non-serious AEs were collected during the treatment (8 weeks at maximum) and taper phases (3 weeks at maximum). SAEs were also collected during the follow-up phase (2 weeks after the last dose of investigational product).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 27 (0%)	9 of 27 (33.3%)	Not reported
Paroxetine	0 of 29 (0%)	9 of 29 (31%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundGSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary with a conclusion.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

33 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing paroxetine 10mg tablet and paroxetine 20mg tablet in people with Depressive Disorder, run by GlaxoSmithKline at 33 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8 (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00812812, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.