Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD)

This study has been terminated.

( difficulty in achieving target enrollment numbers )

Study NCT00557622 Information provided by GlaxoSmithKline

First Received on November 12, 2007. Last Updated on February 12, 2010 History of Changes

Results First Received: September 2, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Posttraumatic Stress Disorder (PTSD)
Interventions:	Drug: paroxetine Other: placebo

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
Prior to assignment to the 12-week treatment phase, all participants received placebo in a single-blind manner in a 4-week run-in phase. Participants completing the run-in phase were then randomized to receive either placebo or paroxetine for the remainder of the study. Two participants were withdrawn from the study before randomization.

Reporting Groups

	Description
Placebo	Placebo once daily (OD)
Paroxetine 20-50 mg/Day	Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.

Participant Flow for 2 periods

Period 1: 4-Week Run-in Phase

	Placebo	Paroxetine 20-50 mg/Day
STARTED	5	0
COMPLETED	3	0
NOT COMPLETED	2	0
Withdrawal by Subject	1	0
Protocol-defined stopping criteria	1	0

Period 2: 12-Week Treatment Phase

	Placebo	Paroxetine 20-50 mg/Day
STARTED	1	2
COMPLETED	1	1
NOT COMPLETED	0	1
Lost to Follow-up	0	1

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo once daily (OD)
Paroxetine 20-50 mg/Day	Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.

Baseline Measures

	Placebo	Paroxetine 20-50 mg/Day	Total
Number of Participants [units: participants]	1	2	3
Age, Customized [units: participants]
39 years old	1	0	1
43 years old	0	1	1
48 years old	0	1	1
Gender [units: participants]
Female	0	1	1
Male	1	1	2
Race/Ethnicity, Customized [units: participants]
Asian-Japanese Heritage	1	2	3
The number of participants with an MVA(Motor Vehicle Accident) of a particular duration ^[1] [units: participants]
23 weeks	0	1	1
25 weeks	0	1	1
54 weeks	1	0	1

[1]	The number of participants who experienced a MVA of various durations with severe or potentially severe physical injury more than 3 months ago

Outcome Measures

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1. Primary:

Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale One Week Symptom Status Version) Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]

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2. Secondary:

Number of Participants With the Indicated Week 0 and Week 12 Z-scores for Regional Blood Flow Using Functional Magnetic Resonance Imaging (fMRI) in the Left Amygdala (LA), Right Amygdala (RA), and the Medial Prefrontal Cortex (MPFC) [ Time Frame: Baseline and Week 12 ]

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3. Secondary:

Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Total Score at Weeks 4 and 8 [ Time Frame: Baseline and Weeks 4 and 8 ]

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4. Secondary:

Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Relating Re-experiencing at Weeks 4, 8, and 12 [ Time Frame: Baseline and Weeks 4, 8, and 12 ]

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5. Secondary:

Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Relating Avoidance and Numbing at Weeks 4, 8, and 12 [ Time Frame: Baseline and Weeks 4, 8, and 12 ]

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6. Secondary:

Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Relating Increased Arousal Symptom at Weeks 4, 8, and 12 [ Time Frame: Baseline and Weeks 4, 8, and 12 ]

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7. Secondary:

Number of Participants With the Indicated Change From Baseline in CGI (Clinical Global Impression) Severity of Illness Scores at Weeks 2, 4, 6, 8, 10, and 12 [ Time Frame: Baseline and Weeks 2, 4, 6, 8, 10, and 12 ]

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8. Secondary:

Number of Participants With the Indicated Clinical Global Impression (CGI) Global Improvement at Week 12 [ Time Frame: Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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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:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00557622 History of Changes
Other Study ID Numbers:	PIR109164
Study First Received:	November 12, 2007
Results First Received:	September 2, 2009
Last Updated:	February 12, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare