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

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00812812

First received: December 18, 2008

Last updated: October 27, 2011

Last verified: October 2011

History of Changes

Results First Received: September 8, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Major Depressive Disorder Depressive Disorder
Interventions:	Drug: paroxetine 10mg tablet Drug: paroxetine 20mg tablet Drug: matched placebo to paroxetine 10mg Drug: matched placebo to paroxetine 20mg

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study consisted of 3 phases: a 2-week placebo run-in phase, an 8-week treatment phase, and a 0- to 3-week taper phase. In the run-in phase, placebo was administered once daily for 2 weeks. In the treatment phase, paroxetine or placebo was orally administered once daily for 8 weeks. In the taper phase, the dose was gradually reduced.

Reporting Groups

Description

Placebo

Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).

Paroxetine

Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase (total of 8 weeks). During the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase, (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.

Participant Flow: Overall Study

	Placebo	Paroxetine
STARTED	27	29
COMPLETED	24	25
NOT COMPLETED	3	4
Adverse Event	2	1
Lack of Efficacy	1	0
Lost to Follow-up	0	1
Withdrawal by Subject	0	2

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
Paroxetine	Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Paroxetine	Total
Number of Participants [units: participants]	27	29	56
Age [units: Years] Mean ± Standard Deviation	14.8 ± 2.62	14.4 ± 1.99	14.6 ± 2.30
Gender [units: Participants]
Female	18	16	34
Male	9	13	22
Race/Ethnicity, Customized [units: participants]	27	29	56

Outcome Measures

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1. Primary:

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

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2. Secondary:

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 ]

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3. Secondary:

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 ]

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4. Secondary:

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 ]

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5. Secondary:

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) ]

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Serious Adverse Events

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Other Adverse Events

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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).
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

Description

Placebo

Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).

Paroxetine

Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.

Other Adverse Events

	Placebo	Paroxetine
Total, other (not including serious) adverse events
# participants affected / at risk	9/27	9/29
Infections and infestations
Nasopharyngitis ^{† 1}
# participants affected / at risk	4/27 (14.81%)	6/29 (20.69%)
Influenza ^{† 1}
# participants affected / at risk	2/27 (7.41%)	1/29 (3.45%)
Nervous system disorders
Headache ^{† 1}
# participants affected / at risk	0/27 (0.00%)	2/29 (6.90%)
Psychiatric disorders
Suicidal ideation ^{† 1}
# participants affected / at risk	3/27 (11.11%)	0/29 (0.00%)
Reproductive system and breast disorders
Dysmenorrhoea ^{† 1}
# participants affected / at risk	2/27 (7.41%)	1/29 (3.45%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA version 13.1

More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00812812 History of Changes
Other Study ID Numbers:	112487
Study First Received:	December 18, 2008
Results First Received:	September 8, 2011
Last Updated:	October 27, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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