Trial Outcomes & Findings for Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD) (NCT NCT00557622)
NCT ID: NCT00557622
Last Updated: 2020-11-30
Results Overview
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.
TERMINATED
PHASE2
5 participants
Baseline and Week 12
2020-11-30
Participant Flow
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 Two participants were withdrawn from the study before randomization.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
4-Week Run-in Phase
STARTED
|
5
|
0
|
|
4-Week Run-in Phase
COMPLETED
|
3
|
0
|
|
4-Week Run-in Phase
NOT COMPLETED
|
2
|
0
|
|
12-Week Treatment Phase
STARTED
|
1
|
2
|
|
12-Week Treatment Phase
COMPLETED
|
1
|
1
|
|
12-Week Treatment Phase
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
4-Week Run-in Phase
Withdrawal by Subject
|
1
|
0
|
|
4-Week Run-in Phase
Protocol-defined stopping criteria
|
1
|
0
|
|
12-Week Treatment Phase
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Placebo
n=1 Participants
Placebo once daily (OD)
|
Paroxetine 20-50 mg/Day
n=2 Participants
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
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
39 years old
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
43 years old
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
48 years old
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese Heritage
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
The number of participants with an MVA(Motor Vehicle Accident) of a particular duration
23 weeks
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
The number of participants with an MVA(Motor Vehicle Accident) of a particular duration
25 weeks
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
The number of participants with an MVA(Motor Vehicle Accident) of a particular duration
54 weeks
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=1 Participants
Placebo once daily (OD)
|
Paroxetine 20-50 mg/Day
n=1 Participants
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.
|
|---|---|---|
|
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
Change from baseline in CAPS-SX=+4
|
0 participants
|
1 participants
|
|
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
Change from baseline in CAPS-SX=-27
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=1 Participants
Placebo once daily (OD)
|
Paroxetine 20-50 mg/Day
n=2 Participants
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.
|
|---|---|---|
|
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)
RA: Week 0, face task, z-score of 4082
|
0 participants
|
1 participants
|
|
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)
LA: Week 0, face task, z-score of 5355
|
0 participants
|
1 participants
|
|
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)
LA: Week 12, MVA task, z-score of 2843
|
1 participants
|
0 participants
|
|
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)
LA: Week 12, face task, z-score of 2054
|
1 participants
|
0 participants
|
|
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)
RA: Week 0, MVA task, z-score of 6310
|
0 participants
|
1 participants
|
|
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)
RA: Week 0, MVA task, z-score of 2549
|
1 participants
|
0 participants
|
|
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)
RA: Week 0, face task, z-score of 3339
|
1 participants
|
0 participants
|
|
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)
RA: Week 12, MVA task, z-score of 2217
|
1 participants
|
0 participants
|
|
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)
RA: Week 12, face task, z-score of 2669
|
1 participants
|
0 participants
|
|
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)
MPFC: Week 0, MVA task, z-score of 10652
|
0 participants
|
1 participants
|
|
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)
MPFC: Week 0, MVA task, z-score of 3072
|
1 participants
|
0 participants
|
|
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)
MPFC: Week 0, face task, z-score of 6162
|
0 participants
|
1 participants
|
|
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)
MPFC: Week 0, face task, z-score of 5718
|
1 participants
|
0 participants
|
|
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)
MPFC: Week 12, MVA task, z-score of 9083
|
1 participants
|
0 participants
|
|
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)
MPFC: Week 12, MVA task, z-score of 3309
|
1 participants
|
0 participants
|
|
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)
LA: Week 0, MVA task, z-score of 6569
|
0 participants
|
1 participants
|
|
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)
LA: Week 0, MVA task, z-score of 2639
|
1 participants
|
0 participants
|
|
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)
LA: Week 0, face task, z-score of 2503
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4 and 8Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=1 Participants
Placebo once daily (OD)
|
Paroxetine 20-50 mg/Day
n=1 Participants
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.
|
|---|---|---|
|
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
Change in CAPS-SX total score=+7, Week 4
|
0 participants
|
1 participants
|
|
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
Change in CAPS-SX total score=-4, Week 4
|
1 participants
|
0 participants
|
|
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
Change in CAPS-SX total score=+10, Week 8
|
0 participants
|
1 participants
|
|
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
Change in CAPS-SX total score=-10, Week 8
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=1 Participants
Placebo once daily (OD)
|
Paroxetine 20-50 mg/Day
n=1 Participants
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.
|
|---|---|---|
|
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
Change in CAPS-SX=+7, Week 4
|
0 participants
|
1 participants
|
|
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
Change in CAPS-SX=-1, Week 4
|
1 participants
|
0 participants
|
|
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
Change in CAPS-SX=+5, Week 8
|
0 participants
|
1 participants
|
|
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
Change in CAPS-SX=-2, Week 8
|
1 participants
|
0 participants
|
|
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
Change in CAPS-SX=+6, Week 12
|
0 participants
|
1 participants
|
|
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
Change in CAPS-SX=-13, Week 12
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=1 Participants
Placebo once daily (OD)
|
Paroxetine 20-50 mg/Day
n=1 Participants
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.
|
|---|---|---|
|
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
Change in CAPS-SX=0, Week 4
|
0 participants
|
1 participants
|
|
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
Change in CAPS-SX=+1, Week 4
|
1 participants
|
0 participants
|
|
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
Change in CAPS-SX=-3, Week 8
|
0 participants
|
1 participants
|
|
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
Change in CAPS-SX=0, Week 8
|
1 participants
|
0 participants
|
|
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
Change in CAPS-SX=-1, Week 12
|
0 participants
|
1 participants
|
|
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
Change in CAPS-SX=-5, Week 12
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, and 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=1 Participants
Placebo once daily (OD)
|
Paroxetine 20-50 mg/Day
n=1 Participants
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.
|
|---|---|---|
|
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
Change in CAPS-SX=0, Week 4
|
0 participants
|
1 participants
|
|
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
Change in CAPS-SX=-4, Week 4
|
1 participants
|
0 participants
|
|
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
Change in CAPS-SX=+8, Week 8
|
0 participants
|
1 participants
|
|
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
Change in CAPS-SX=-8, Week 8
|
1 participants
|
0 participants
|
|
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
Change in CAPS-SX=-1, Week 12
|
0 participants
|
1 participants
|
|
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
Change in CAPS-SX=-9, Week 12
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, 8, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=1 Participants
Placebo once daily (OD)
|
Paroxetine 20-50 mg/Day
n=1 Participants
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.
|
|---|---|---|
|
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
Change in CGI Severity of Illness=0, Week 10
|
1 participants
|
1 participants
|
|
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
Change in CGI Severity of Illness=0, Week 2
|
1 participants
|
0 participants
|
|
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
Change in CGI Severity of Illness=-1, Week 2
|
0 participants
|
1 participants
|
|
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
Change in CGI Severity of Illness=0, Week 4
|
1 participants
|
1 participants
|
|
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
Change in CGI Severity of Illness=0, Week 6
|
1 participants
|
1 participants
|
|
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
Change in CGI Severity of Illness=0, Week 8
|
1 participants
|
1 participants
|
|
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
Change in CGI Severity of Illness=0, Week 12
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=1 Participants
Placebo once daily (OD)
|
Paroxetine 20-50 mg/Day
n=1 Participants
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.
|
|---|---|---|
|
Number of Participants With a Clinical Global Impression (CGI) Global Improvement of 4 at Week 12
|
1 participants
|
1 participants
|
Adverse Events
Placebo
Paroxetine 20-50 mg/Day
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=1 participants at risk
Placebo once daily (OD)
|
Paroxetine 20-50 mg/Day
n=2 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1
|
50.0%
1/2
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
0.00%
0/1
|
50.0%
1/2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1
|
50.0%
1/2
|
|
Hepatobiliary disorders
Gamma-glutamyltransferase increased
|
100.0%
1/1
|
0.00%
0/2
|
|
Nervous system disorders
Somnolence
|
100.0%
1/1
|
0.00%
0/2
|
|
Psychiatric disorders
Muscle tightness
|
100.0%
1/1
|
0.00%
0/2
|
|
Eye disorders
Chorioretinopathy
|
100.0%
1/1
|
0.00%
0/2
|
|
Infections and infestations
Nasopharyngitis
|
100.0%
1/1
|
0.00%
0/2
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER