| Primary | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Thus total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented. | Intent-to-treat population | Posted | | Number | | cumulative percent of responders | | 10 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| | Units | Counts |
|---|
| Participants | - OG000125
- OG001120
- OG00267
- OG003
|
| | Title | Denominators | Categories |
|---|
| Week 1 | | | Title | Measurements |
|---|
| - OG0001.60
- OG0010.83
- OG0021.49
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups. | Generalized Wilcoxon | | 0.1143 | | | | | | | 95 | | | | | | No | Superiority or Other | | | | This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups. |
|
| Secondary | Change From Baseline in the Total HAM-A Score After 1 Week | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. | ITT population, but only subjects with values at baseline and time point are included in the analysis | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 1 week | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in the Total HAM-A Score After 2 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. | ITT Population, only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 2 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in the Total HAM-A Score After 3 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. | ITT population, only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 3 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in the Total HAM-A Score After 4 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. | ITT population, only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in the Total HAM-A Score After 5 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. | ITT population, only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 5 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in the Total HAM-A Score After 6 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. | ITT population, only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in the Total HAM-A Score After 7 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. | ITT population, only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 7 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in the Total HAM-A Score After 8 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. | ITT population, only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. Endpoint is last observed value during the 8 week treatment period. | ITT population, Last Observation Carried Forward imputation was applied | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and at endpoint during the 8 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
|
| Secondary | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). | ITT population, but only patients with a non-missing value at timepoint are included in the analysis | Posted | | Number | | participants | | 1 week | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). | ITT population, but only patients with a non-missing value at timepoint are included in the analysis | Posted | | Number | | participants | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). | ITT population, but only patients with a non-missing value at timepoint are included in the analysis | Posted | | Number | | participants | | 3 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). | ITT population, but only patients with a non-missing value at timepoint are included in the analysis | Posted | | Number | | participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). | ITT population, but only patients with a non-missing value at timepoint are included in the analysis | Posted | | Number | | participants | | 5 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). | ITT population, but only patients with a non-missing value at timepoint are included in the analysis | Posted | | Number | | participants | | 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). | ITT population, but only patients with a non-missing value at timepoint are included in the analysis | Posted | | Number | | participants | | 7 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). | ITT population, but only patients with a non-missing value at timepoint are included in the analysis | Posted | | Number | | participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Endpoint is last observed value during the 8 week treatment period. | ITT population, Last Observation Carried Forward imputation was applied | Posted | | Number | | participants | | at endpoint during the 8 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
|
| Secondary | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). | ITT population, but only patients with non-missing values were included | Posted | | Number | | Participants | | Baseline and 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
|
| Secondary | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
|
| Secondary | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | Baseline and 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
|
| Secondary | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). Endpoint is last observed value during the 8 week treatment period. | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | Baseline and at endpoint during the 8 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | |
|
| Secondary | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). | ITT population, but only patients with non-missing values are included in the analysis | Posted | | Number | | participants | | 1 week | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect. | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | 3 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | 5 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | 7 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). | ITT population, Last Observation Carried Forward imputation was applied | Posted | | Number | | participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). Endpoint is last observed value during the 8 week treatment period. | ITT population, Last Observation Carried Forward imputation was applied | Posted | | Number | | participants | | at endpoint during the 8 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
|
| Secondary | Change From Baseline in HAM-A-insomnia Subscore After 1 Week | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 1 week | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 3 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 5 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 7 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. Endpoint is last observed value during the 8 week treatment period. | ITT population, Last Observation Carried Forward imputation was applied | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and at endpoint during the 8 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
|
| Secondary | Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 1 week | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 3 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 5 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 7 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. Endpoint is last observed value during the 8 week treatment period. | ITT population, Last Observation Carried Forward imputation was applied | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and at endpoint during the 8 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | |
|
| Secondary | Change From Baseline in HAM-A-somatic Subscore After 1 Week | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 1 week | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-somatic Subscore After 2 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-somatic Subscore After 3 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 3 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-somatic Subscore After 4 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-somatic Subscore After 5 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 5 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-somatic Subscore After 6 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-somatic Subscore After 7 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 7 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-somatic Subscore After 8 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. | ITT population, but only subjects with non-missing values have been included | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
| |
| Secondary | Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. Endpoint is last observed value during the 8 week treatment period. | ITT population, Last Observation Carried Forward imputation was applied | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and at endpoint during the 8 week treatment period | | | | ID | Title | Description |
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| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
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| Secondary | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week | | ITT population, but only patients with non-missing assessments were included | Posted | | Number | | participants | | 1 week | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
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| Secondary | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks | | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
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| Secondary | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks | | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | 3 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
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| Secondary | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks | | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
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| Secondary | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks | | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | 5 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
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| Secondary | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks | | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
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| Secondary | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks | | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | 7 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
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| Secondary | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks | | ITT population, but only subjects with non-missing values have been included | Posted | | Number | | participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
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| Secondary | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period | Endpoint is last observed value during the 8 week treatment period. | ITT population, Last Observation Carried Forward imputation was applied | Posted | | Number | | participants | | at endpoint during the 8 week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone | Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone |
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| Primary | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented. | Per Protocol Population (subjects of ITT population who have no major protocol violations) | Posted | | Number | | cumulative percent of responders | | 10 weeks | | | | ID | Title | Description |
|---|
| OG000 | Panic: Niravam+SSRI/SNRI | Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | | OG001 | Panic: SSRI/SNRI Alone | Panic Disorder: Newly prescribed SSRI or SNRI alone | | OG002 | GAD : Niravam+SSRI/SNRI | Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | | OG003 | GAD: SSRI/SNRI Alone |
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