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

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ClinicalTrials.gov Identifier: NCT00557622
Recruitment Status : Terminated (difficulty in achieving target enrollment numbers)
First Posted : November 14, 2007
Results First Posted : November 19, 2009
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Post-Traumatic Stress Disorder
Interventions Drug: paroxetine
Other: placebo
Enrollment 5
Recruitment Details  
Pre-assignment Details 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 Two participants were withdrawn from the study before randomization.
Arm/Group Title Placebo Paroxetine 20-50 mg/Day
Hide Arm/Group Description Placebo once daily (OD) 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.
Period Title: 4-Week Run-in Phase
Started 5 0
Completed 3 0
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             1             0
Protocol-defined stopping criteria             1             0
Period Title: 12-Week Treatment Phase
Started 1 2
Completed 1 1
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Placebo Paroxetine 20-50 mg/Day Total
Hide Arm/Group Description Placebo once daily (OD) 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. Total of all reporting groups
Overall Number of Baseline Participants 1 2 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
39 years old 1 0 1
43 years old 0 1 1
48 years old 0 1 1
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
Female
0
   0.0%
1
  50.0%
1
  33.3%
Male
1
 100.0%
1
  50.0%
2
  66.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian-Japanese Heritage Number Analyzed 1 participants 2 participants 3 participants
1 2 3
The number of participants with an MVA(Motor Vehicle Accident) of a particular duration   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
23 weeks 0 1 1
25 weeks 0 1 1
54 weeks 1 0 1
[1]
Measure Description: The number of participants who experienced a MVA of various durations with severe or potentially severe physical injury more than 3 months ago
1.Primary Outcome
Title 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
Hide Description The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.
Arm/Group Title Placebo Paroxetine 20-50 mg/Day
Hide Arm/Group Description:
Placebo once daily (OD)
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.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: participants
Change from baseline in CAPS-SX=+4 0 1
Change from baseline in CAPS-SX=-27 1 0
2.Secondary Outcome
Title 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)
Hide Description Change in regional blood flow (rCBF) measured by fMRI represents altered neuronal responses in PTSD patients and is considered to be the biomarker for treatment response. fMRI measures are provided as blood oxygeneration level-dependent (BOLD) signals (z-score). To trigger neuronal activation, 2 visual stimuli were used: MVA-task (consisting of MVA-related and unpleasant pictures) and face-task (consisting of a variety of facial expressions [e.g., neutral, happy, fear]). Week 0 and 12 rCBF data from 1 participant were invalid (involuntary movement in the fMRI machine); no analysis was done.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.
Arm/Group Title Placebo Paroxetine 20-50 mg/Day
Hide Arm/Group Description:
Placebo once daily (OD)
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.
Overall Number of Participants Analyzed 1 2
Measure Type: Number
Unit of Measure: participants
LA: Week 0, MVA task, z-score of 6569 0 1
LA: Week 0, MVA task, z-score of 2639 1 0
LA: Week 0, face task, z-score of 5355 0 1
LA: Week 0, face task, z-score of 2503 1 0
LA: Week 12, MVA task, z-score of 2843 1 0
LA: Week 12, face task, z-score of 2054 1 0
RA: Week 0, MVA task, z-score of 6310 0 1
RA: Week 0, MVA task, z-score of 2549 1 0
RA: Week 0, face task, z-score of 4082 0 1
RA: Week 0, face task, z-score of 3339 1 0
RA: Week 12, MVA task, z-score of 2217 1 0
RA: Week 12, face task, z-score of 2669 1 0
MPFC: Week 0, MVA task, z-score of 10652 0 1
MPFC: Week 0, MVA task, z-score of 3072 1 0
MPFC: Week 0, face task, z-score of 6162 0 1
MPFC: Week 0, face task, z-score of 5718 1 0
MPFC: Week 12, MVA task, z-score of 9083 1 0
MPFC: Week 12, MVA task, z-score of 3309 1 0
3.Secondary Outcome
Title 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
Hide Description The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.
Time Frame Baseline and Weeks 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.
Arm/Group Title Placebo Paroxetine 20-50 mg/Day
Hide Arm/Group Description:
Placebo once daily (OD)
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.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: participants
Change in CAPS-SX total score=+7, Week 4 0 1
Change in CAPS-SX total score=-4, Week 4 1 0
Change in CAPS-SX total score=+10, Week 8 0 1
Change in CAPS-SX total score=-10, Week 8 1 0
4.Secondary Outcome
Title 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
Hide Description The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.
Time Frame Baseline and Weeks 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.
Arm/Group Title Placebo Paroxetine 20-50 mg/Day
Hide Arm/Group Description:
Placebo once daily (OD)
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.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: participants
Change in CAPS-SX=+7, Week 4 0 1
Change in CAPS-SX=-1, Week 4 1 0
Change in CAPS-SX=+5, Week 8 0 1
Change in CAPS-SX=-2, Week 8 1 0
Change in CAPS-SX=+6, Week 12 0 1
Change in CAPS-SX=-13, Week 12 1 0
5.Secondary Outcome
Title 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
Hide Description The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.
Time Frame Baseline and Weeks 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.
Arm/Group Title Placebo Paroxetine 20-50 mg/Day
Hide Arm/Group Description:
Placebo once daily (OD)
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.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: participants
Change in CAPS-SX=0, Week 4 0 1
Change in CAPS-SX=+1, Week 4 1 0
Change in CAPS-SX=-3, Week 8 0 1
Change in CAPS-SX=0, Week 8 1 0
Change in CAPS-SX=-1, Week 12 0 1
Change in CAPS-SX=-5, Week 12 1 0
6.Secondary Outcome
Title 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
Hide Description The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.
Time Frame Baseline and Weeks 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.
Arm/Group Title Placebo Paroxetine 20-50 mg/Day
Hide Arm/Group Description:
Placebo once daily (OD)
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.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: participants
Change in CAPS-SX=0, Week 4 0 1
Change in CAPS-SX=-4, Week 4 1 0
Change in CAPS-SX=+8, Week 8 0 1
Change in CAPS-SX=-8, Week 8 1 0
Change in CAPS-SX=-1, Week 12 0 1
Change in CAPS-SX=-9, Week 12 1 0
7.Secondary Outcome
Title 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
Hide Description The participant's status was assessed using the following 8-point 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; 7, Among the most extremely ill patients.
Time Frame Baseline and Weeks 2, 4, 6, 8, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.
Arm/Group Title Placebo Paroxetine 20-50 mg/Day
Hide Arm/Group Description:
Placebo once daily (OD)
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.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: participants
Change in CGI Severity of Illness=0, Week 2 1 0
Change in CGI Severity of Illness=-1, Week 2 0 1
Change in CGI Severity of Illness=0, Week 4 1 1
Change in CGI Severity of Illness=0, Week 6 1 1
Change in CGI Severity of Illness=0, Week 8 1 1
Change in CGI Severity of Illness=0, Week 10 1 1
Change in CGI Severity of Illness=0, Week 12 1 1
8.Secondary Outcome
Title Number of Participants With a Clinical Global Impression (CGI) Global Improvement of 4 at Week 12
Hide Description The participant's status was assessed using the following 8-point scale: 0, Not assessed; 1,Very much improved; 2, Much Improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; 7, Very much worse.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.
Arm/Group Title Placebo Paroxetine 20-50 mg/Day
Hide Arm/Group Description:
Placebo once daily (OD)
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.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: participants
1 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Paroxetine 20-50 mg/Day
Hide Arm/Group Description Placebo once daily (OD) 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.
All-Cause Mortality
Placebo Paroxetine 20-50 mg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Paroxetine 20-50 mg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Paroxetine 20-50 mg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   1/2 (50.00%) 
Eye disorders     
Chorioretinopathy  1  1/1 (100.00%)  0/2 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  0/1 (0.00%)  1/2 (50.00%) 
Hepatobiliary disorders     
Alanine aminotransferase increased  1  0/1 (0.00%)  1/2 (50.00%) 
Gamma-glutamyltransferase increased  1  1/1 (100.00%)  0/2 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  1/1 (100.00%)  0/2 (0.00%) 
Nervous system disorders     
Somnolence  1  1/1 (100.00%)  0/2 (0.00%) 
Psychiatric disorders     
Muscle tightness  1  1/1 (100.00%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  0/1 (0.00%)  1/2 (50.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
This study has not been published in the scientific literature.
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00557622     History of Changes
Other Study ID Numbers: PIR109164
First Submitted: November 12, 2007
First Posted: November 14, 2007
Results First Submitted: September 2, 2009
Results First Posted: November 19, 2009
Last Update Posted: December 28, 2016