Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder

Study Overview
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Brief Summary
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An 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in symptoms of anxiety in subjects treated with Niravam™ and a newly prescribed Selective Serotonin Reuptake Inhibitor (SSRI)or Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) to that in subjects treated with a newly prescribed SSRI/SNRI alone. Subjects must be at least 18 years of age and positive for Generalized Anxiety Disorder (GAD)or Panic Disorder. Subjects will be randomized to receive concomitant Niravam™ and an SSRI/SNRI or an SSRI/SNRI alone during the study. Most symptom evaluations will be done using an automated phone interview system. There are 4 clinic visits.

Official Title
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A Multicenter, Randomized, Open-label, Parallel Design Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder

Conditions
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Generalized Anxiety Disorder, Panic Disorder

Intervention / Treatment
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* Drug: Niravam
* Drug: SSRI/SNRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be at least 18 years of age. Diagnosed by the Investigator with primary Generalized Anxiety Disorder (GAD) and/or primary Panic Disorder with or without agoraphobia, either primary episode or recurrence, and is positive for GAD or Panic Disorder by the MHS (Mental Health Screener)). Receiving a new prescription for all SSRI or SNRI as indicated for GAD or Panic Disorder with or without agoraphobia. Definition of a new prescription in case of a recurrence in symptoms is no prescription or refill of prescription of SSRI or SNRI for the past 6 months. Subject is informed and given ample time and opportunity to think about his/her participation and has given his/her written informed consent. Exclusion Criteria: Presence of medical condition or presence of schizophrenia, bipolar disorder, alcohol abuse/dependence or any other primary major psychiatric disorder that, in the opinion of the Investigator, would jeopardize the subject or compromise the subject's ability to participate in the trial. Is a current suicide risk in the opinion of the Investigator. Has initiated cognitive therapy within two months of Study Day 1. Does not speak English or does not hear well enough to be able to perform the Hamilton Anxiety (HAM-A) Rating Scale and Mental Health Screener (MHS) by Interactive Voice Response System (IVRS). Has taken a benzodiazepine within the past 30 days. History of hypersensitivity or allergic response to any of the components of SSRIs, SNRIs, benzodiazepines, or related drugs. If a female of child-bearing potential, is pregnant, nursing, or not using appropriate birth control methods. Presence of contraindications to the SSRI or SNRI to be prescribed per the specific package insert. Presence of acute narrow angle glaucoma or taking ketoconazole or itraconazole,which are contraindications to Niravam per the package insert. History of phenylketonuria (PKU). Participation in a previous clinical trial within 30 days prior to Study Day 1.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Panic: Niravam+SSRI/SNRI<br>Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | Drug: Niravam<br> <br> * Other names: Alprazolam;Drug: SSRI/SNRI<br>* Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor<br>|
| Experimental: Panic: SSRI/SNRI alone<br>Panic Disorder: Newly prescribed SSRI or SNRI alone | Drug: SSRI/SNRI<br>* Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor<br>|
| Experimental: GAD: Niravam+SSRI/SNRI<br>Generalized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI | Drug: Niravam<br> <br> * Other names: Alprazolam;Drug: SSRI/SNRI<br>* Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor<br>|
| Experimental: GAD: SSRI/SNRI alone<br>Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone | Drug: SSRI/SNRI<br>* Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 weeks | 
| 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. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 1 week | 
| 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. | Baseline and 2 Weeks | 
| 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. | Baseline and 3 weeks | 
| 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. | Baseline and 4 weeks | 
| 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. | Baseline and 5 weeks | 
| 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. | Baseline and 6 weeks | 
| 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. | Baseline and 7 weeks | 
| 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. | Baseline and 8 weeks | 
| 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. | Baseline and at endpoint during the 8 week treatment period | 
| 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). | 1 week | 
| 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). | 2 weeks | 
| 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). | 3 weeks | 
| 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). | 4 weeks | 
| 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). | 5 weeks | 
| 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). | 6 weeks | 
| 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). | 7 weeks | 
| 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). | 8 weeks | 
| 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. | at endpoint during the 8 week treatment period | 
| 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). | Baseline and 2 weeks | 
| 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). | Baseline and 4 weeks | 
| 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). | Baseline and 8 weeks | 
| 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. | Baseline and at endpoint during the 8 week treatment period | 
| 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). | 1 week | 
| 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. | 2 weeks | 
| 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). | 3 weeks | 
| 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). | 4 weeks | 
| 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). | 5 weeks | 
| 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). | 6 weeks | 
| 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). | 7 weeks | 
| 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). | 8 weeks | 
| 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. | at endpoint during the 8 week treatment period | 
| 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. | Baseline and 1 week | 
| 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. | Baseline and 2 weeks | 
| 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. | Baseline and 3 weeks | 
| 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. | Baseline and 4 weeks | 
| 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. | Baseline and 5 weeks | 
| 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. | Baseline and 6 weeks | 
| 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. | Baseline and 7 weeks | 
| 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. | Baseline and 8 weeks | 
| 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. | Baseline and at endpoint during the 8 week treatment period | 
| 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. | Baseline and 1 week | 
| 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. | Baseline and 2 weeks | 
| 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. | Baseline and 3 weeks | 
| 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. | Baseline and 4 weeks | 
| 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. | Baseline and 5 weeks | 
| 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. | Baseline and 6 weeks | 
| 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. | Baseline and 7 weeks | 
| 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. | Baseline and 8 weeks | 
| 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. | Baseline and at endpoint during the 8 week treatment period | 
| 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. | Baseline and 1 week | 
| 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. | Baseline and 2 weeks | 
| 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. | Baseline and 3 weeks | 
| 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. | Baseline and 4 weeks | 
| 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. | Baseline and 5 weeks | 
| 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. | Baseline and 6 weeks | 
| 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. | Baseline and 7 weeks | 
| 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. | Baseline and 8 weeks | 
| 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. | Baseline and at endpoint during the 8 week treatment period | 
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week |  | 1 week | 
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks |  | 2 weeks | 
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks |  | 3 weeks | 
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks |  | 4 weeks | 
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks |  | 5 weeks | 
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks |  | 6 weeks | 
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks |  | 7 weeks | 
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks |  | 8 weeks | 
| 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. | at endpoint during the 8 week treatment period |