Adults 20 to 65, any sex, with Post-Traumatic Stress Disorder or Stress Disorders, Post-Traumatic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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 12Primary· Baseline and Week 12
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.
Change from baseline in CAPS-SX=+4
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
Change from baseline in CAPS-SX=-27
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
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)Secondary· Baseline and Week 12
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.
LA: Week 0, MVA task, z-score of 6569
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
LA: Week 0, MVA task, z-score of 2639
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
LA: Week 0, face task, z-score of 5355
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
LA: Week 0, face task, z-score of 2503
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
LA: Week 12, MVA task, z-score of 2843
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
LA: Week 12, face task, z-score of 2054
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
RA: Week 0, MVA task, z-score of 6310
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
RA: Week 0, MVA task, z-score of 2549
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
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 8Secondary· Baseline and Weeks 4 and 8
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.
Change in CAPS-SX total score=+7, Week 4
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
Change in CAPS-SX total score=-4, Week 4
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
Change in CAPS-SX total score=+10, Week 8
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
Change in CAPS-SX total score=-10, Week 8
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
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 12Secondary· Baseline and Weeks 4, 8, and 12
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.
Change in CAPS-SX=+7, Week 4
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
Change in CAPS-SX=-1, Week 4
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
Change in CAPS-SX=+5, Week 8
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
Change in CAPS-SX=-2, Week 8
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
Change in CAPS-SX=+6, Week 12
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
Change in CAPS-SX=-13, Week 12
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
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 12Secondary· Baseline and Weeks 4, 8, and 12
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.
Change in CAPS-SX=0, Week 4
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
Change in CAPS-SX=+1, Week 4
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
Change in CAPS-SX=-3, Week 8
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
Change in CAPS-SX=0, Week 8
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
Change in CAPS-SX=-1, Week 12
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
Change in CAPS-SX=-5, Week 12
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
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 12Secondary· Baseline and Weeks 4, 8, and 12
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.
Change in CAPS-SX=0, Week 4
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
Change in CAPS-SX=-4, Week 4
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
Change in CAPS-SX=+8, Week 8
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
Change in CAPS-SX=-8, Week 8
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
Change in CAPS-SX=-1, Week 12
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
Change in CAPS-SX=-9, Week 12
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
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 12Secondary· Baseline and Weeks 2, 4, 6, 8, 10, and 12
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.
Change in CGI Severity of Illness=0, Week 2
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
0
Change in CGI Severity of Illness=-1, Week 2
Group
Value
95% CI
Placebo
0
Paroxetine 20-50 mg/Day
1
Change in CGI Severity of Illness=0, Week 4
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
1
Change in CGI Severity of Illness=0, Week 6
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
1
Change in CGI Severity of Illness=0, Week 8
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
1
Change in CGI Severity of Illness=0, Week 10
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
1
Change in CGI Severity of Illness=0, Week 12
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
1
Number of Participants With a Clinical Global Impression (CGI) Global Improvement of 4 at Week 12Secondary· Week 12
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.
Group
Value
95% CI
Placebo
1
Paroxetine 20-50 mg/Day
1
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a single-blind, placebo-controlled, parallel group study to evaluate the efficacy of BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over the dose range of 20 mg to 50 mg once daily after supper for 12 weeks in Japanese patients with posttraumatic stress disorder (PTSD) as assessed by the change from baseline in CAPS-SX total score. Also the effect of paroxetine on regional cerebral blood flow (rCBF) induced by subthreshold emotional arousing (or symptom stimulating) tasks will be determined using functional magnetic resonance imaging (fMRI) for exploratory assessment of the correlation between the change in rCBF and the efficacy.
The sample size is 30 subjects. The study period consists of 4 weeks of run-in phase, 12 weeks of treatment phase, 0-3 weeks of taper phase and follow-up examination at 2 weeks after the last dose, for a total of 18-21 weeks.
Subjects will visit the clinic at the start of run-in phase, Week -2, the start of treatment phase, Weeks 2, 4, 6, 8 and 12 of treatment, and follow-up examination.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 30 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00557622.