Post-Traumatic Stress Disorder, Stress Disorders, Post-Traumatic
Conditions
Keywords
PTSD (Posttraumatic Stress Disorder), CAPS, fMRI, Paroxetine
Brief summary
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.
Interventions
DRUGparoxetine
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)
OTHERplacebo
placebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are primarily diagnosed with PTSD (Posttraumatic Stress Disorder: 309.81) using DSM-IV-TR criteria. The CAPS-DX (Clinician-Administered PTSD Scale-DX) and M.I.N.I. (The Mini International Neuropsychiatric Interview, Japanese version 5.0.0. \[2003\]) will be used for diagnosis * Pathologic condition: Patients who experienced a motor vehicle accident (MVA) with severe or potential severe physical injury more than 3 months ago but less than 12 months ago * Patients aged 20 and \<65 at the time of signing the Informed consent * Male and female patients * Inpatient/outpatient status: Both are permitted * Patients who are able to give written informed consent in person (i.e., patients who are capable of giving written informed consent on their own) * Patients whose combined score of the CAPS-SX standard B, C, and D is over 50
Exclusion criteria
* Patients primarily diagnosed with a DSM-IV-TR Axis I disorder other than PTSD (e.g. major depressive disorder, dysthymic disorder, specific phobia \[simple phobia\], obsessive-compulsive disorder, panic disorder, etc.) within 6 months of week -4 (start of baseline phase) * Patients presenting with a current major depressive episode that preceded the diagnosis of PTSD * Patients receiving disability payments due to PTSD or other psychiatric diseases * Patients currently engaged in compensation litigation whereby personal gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders * Patients who meet the DSM-IV-TR criteria for substance abuse or dependence (alcohol or drugs) within 6 months of Week -4 (start of baseline phase) * Patients with history of a suicide attempt within 6 months before Week -4 (start of baseline phase), or have, in the opinion of the investigator, C. high risk of suicide according to the MINI at Week -4 * Patients who are pregnant, lactating or of childbearing potential and are likely to become pregnant * Patients receiving electro-convulsive therapy (ECT) prior to Week -4 (start of baseline phase) * Patients receiving another investigational product within 12 weeks before Week -4 (start of baseline phase) * Patients with a history or complication of manic psychosis * Patients with a history or complication of convulsive disorder (epilepsy, etc.) * Patients with a diagnosis or complication of a cognitive disorder (MMSE \<=24 points) * Patients with a history and complication of serious cerebral organic disorder. (e.g. cerebrovascular disorder, meningitis, degenerative disease and other neurological disorders and seizures; however, bleeding in the upper arachnoid membrane should not be excluded) * Patients unable or unwilling to undergo the fMRI procedure (e.g., cerebrovascular clipping surgery, pacemaker, any internal metals with magnetism, and claustrophobia) * Patients with glaucoma * Patients with a known tendency for bleeding or those with predisposing conditions * Patients with a history of hypersensitivity to paroxetine * Patients with serious physical symptoms (cardiac, hepatic and renal dysfunction, or hematopoietic dysfunction, etc.). For seriousness, Grade 3 of Criteria for seriousness of adverse reactions to drugs, etc. (Yakuan No.80) is used as an index * Patients with a history or complication of cancer or malignant tumour * Patients with chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody * Others whom the investigator or sub-investigator considers ineligible for or unable to participate in the investigation * Criteria at Week 0 (start of Treatment Phase): Subjects whose drug compliance rate for Drug 1 (Run-in Phase placebo) is \<80% between Week -4 and Week 0; Subjects whose CAPS-SX total score of the standard B, C, and D at Week 0 varied by 25% or more compared with those at Week -2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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) | 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. |
| 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 | 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. |
| Number of Participants With a Clinical Global Impression (CGI) Global Improvement of 4 at Week 12 | 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. |
| 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 | 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. |
Countries
Japan
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo once daily (OD) | 1 |
| 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. | 2 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-Week Treatment Phase | Lost to Follow-up | 0 | 1 |
| 4-Week Run-in Phase | Protocol-defined stopping criteria | 1 | 0 |
| 4-Week Run-in Phase | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Paroxetine 20-50 mg/Day | Placebo |
|---|---|---|---|
| Age, Customized 39 years old | 1 participants | 0 participants | 1 participants |
| Age, Customized 43 years old | 1 participants | 1 participants | 0 participants |
| Age, Customized 48 years old | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Asian-Japanese Heritage | 3 participants | 2 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 1 Participants |
| The number of participants with an MVA(Motor Vehicle Accident) of a particular duration 23 weeks | 1 participants | 1 participants | 0 participants |
| The number of participants with an MVA(Motor Vehicle Accident) of a particular duration 25 weeks | 1 participants | 1 participants | 0 participants |
| The number of participants with an MVA(Motor Vehicle Accident) of a particular duration 54 weeks | 1 participants | 0 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 1 | 1 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
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
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
Secondary
Number of Participants With a Clinical Global Impression (CGI) Global Improvement of 4 at 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.
Time frame: Week 12
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With a Clinical Global Impression (CGI) Global Improvement of 4 at Week 12 | 1 participants |
| Paroxetine 20-50 mg/Day | Number of Participants With a Clinical Global Impression (CGI) Global Improvement of 4 at Week 12 | 1 participants |
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
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
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
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
| Paroxetine 20-50 mg/Day | 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 |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 |
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
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
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
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Paroxetine 20-50 mg/Day | 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 |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
| Paroxetine 20-50 mg/Day | 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 |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
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
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Paroxetine 20-50 mg/Day | 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 |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
| Paroxetine 20-50 mg/Day | 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 |
| Paroxetine 20-50 mg/Day | 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 |
| Paroxetine 20-50 mg/Day | 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 |
| Paroxetine 20-50 mg/Day | 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 |
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)
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 0 participants |
| Paroxetine 20-50 mg/Day | 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 | 1 participants |