Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants Flow shows 418 subjects that have been enrolled and randomized. The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Baseline Characteristics are only available for the Intent-to-treat population (subjects who received one dose of SSRI/SNRI and/or Niravam and have an assessment beyond the Baseline assessment)

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Participant Flow:   Overall Study

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
STARTED	137	138	72	71
COMPLETED	92	92	55	49
NOT COMPLETED	45	46	17	22
Lack of Efficacy	2	6	1	2
Adverse Event	7	2	1	1
Lost to Follow-up	18	21	6	8
Withdrawal by Subject	6	10	3	9
Protocol Violation	5	3	4	2
unspecified	7	4	2	0

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Baseline Measures

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone	Total
Number of Participants   [units: participants]	125	120	67	62	374
Age   [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	120	119	66	61	366
>=65 years	5	1	1	1	8
Age   [units: years] Mean ± Standard Deviation	40.1  ± 12.24	38.1  ± 12.55	40.1  ± 12.64	43.6  ± 12.20	40  ± 12
Gender   [units: participants]
Female	102	93	50	42	287
Male	23	27	17	20	87
Region of Enrollment   [units: participants]
United States	125	120	67	62	374

1.  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)   [ Time Frame: 10 weeks ]

2.  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)   [ Time Frame: 10 weeks ]

3.  Secondary:

Change From Baseline in the Total HAM-A Score After 1 Week   [ Time Frame: Baseline and 1 week ]

4.  Secondary:

Change From Baseline in the Total HAM-A Score After 2 Weeks   [ Time Frame: Baseline and 2 Weeks ]

5.  Secondary:

Change From Baseline in the Total HAM-A Score After 3 Weeks   [ Time Frame: Baseline and 3 weeks ]

6.  Secondary:

Change From Baseline in the Total HAM-A Score After 4 Weeks   [ Time Frame: Baseline and 4 weeks ]

7.  Secondary:

Change From Baseline in the Total HAM-A Score After 5 Weeks   [ Time Frame: Baseline and 5 weeks ]

8.  Secondary:

Change From Baseline in the Total HAM-A Score After 6 Weeks   [ Time Frame: Baseline and 6 weeks ]

9.  Secondary:

Change From Baseline in the Total HAM-A Score After 7 Weeks   [ Time Frame: Baseline and 7 weeks ]

10.  Secondary:

Change From Baseline in the Total HAM-A Score After 8 Weeks   [ Time Frame: Baseline and 8 weeks ]

11.  Secondary:

Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period   [ Time Frame: Baseline and at endpoint during the 8 week treatment period ]

12.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week   [ Time Frame: 1 week ]

13.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks   [ Time Frame: 2 weeks ]

14.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks   [ Time Frame: 3 weeks ]

15.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks   [ Time Frame: 4 weeks ]

16.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks   [ Time Frame: 5 weeks ]

17.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks   [ Time Frame: 6 weeks ]

18.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks   [ Time Frame: 7 weeks ]

19.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks   [ Time Frame: 8 weeks ]

20.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period   [ Time Frame: at endpoint during the 8 week treatment period ]

21.  Secondary:

Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks   [ Time Frame: Baseline and 2 weeks ]

22.  Secondary:

Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks   [ Time Frame: Baseline and 4 weeks ]

23.  Secondary:

Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks   [ Time Frame: Baseline and 8 weeks ]

24.  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   [ Time Frame: Baseline and at endpoint during the 8 week treatment period ]

25.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week   [ Time Frame: 1 week ]

26.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks   [ Time Frame: 2 weeks ]

27.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks   [ Time Frame: 3 weeks ]

28.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks   [ Time Frame: 4 weeks ]

29.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks   [ Time Frame: 5 weeks ]

30.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks   [ Time Frame: 6 weeks ]

31.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks   [ Time Frame: 7 weeks ]

32.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks   [ Time Frame: 8 weeks ]

33.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period   [ Time Frame: at endpoint during the 8 week treatment period ]

34.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 1 Week   [ Time Frame: Baseline and 1 week ]

35.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks   [ Time Frame: Baseline and 2 weeks ]

36.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks   [ Time Frame: Baseline and 3 weeks ]

37.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks   [ Time Frame: Baseline and 4 weeks ]

38.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks   [ Time Frame: Baseline and 5 weeks ]

39.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks   [ Time Frame: Baseline and 6 weeks ]

40.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks   [ Time Frame: Baseline and 7 weeks ]

41.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks   [ Time Frame: Baseline and 8 weeks ]

42.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period   [ Time Frame: Baseline and at endpoint during the 8 week treatment period ]

43.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week   [ Time Frame: Baseline and 1 week ]

44.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks   [ Time Frame: Baseline and 2 weeks ]

45.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks   [ Time Frame: Baseline and 3 weeks ]

46.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks   [ Time Frame: Baseline and 4 weeks ]

47.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks   [ Time Frame: Baseline and 5 weeks ]

48.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks   [ Time Frame: Baseline and 6 weeks ]

49.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks   [ Time Frame: Baseline and 7 weeks ]

50.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks   [ Time Frame: Baseline and 8 weeks ]

51.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period   [ Time Frame: Baseline and at endpoint during the 8 week treatment period ]

52.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 1 Week   [ Time Frame: Baseline and 1 week ]

53.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 2 Weeks   [ Time Frame: Baseline and 2 weeks ]

54.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 3 Weeks   [ Time Frame: Baseline and 3 weeks ]

55.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 4 Weeks   [ Time Frame: Baseline and 4 weeks ]

56.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 5 Weeks   [ Time Frame: Baseline and 5 weeks ]

57.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 6 Weeks   [ Time Frame: Baseline and 6 weeks ]

58.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 7 Weeks   [ Time Frame: Baseline and 7 weeks ]

59.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 8 Weeks   [ Time Frame: Baseline and 8 weeks ]

60.  Secondary:

Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period   [ Time Frame: Baseline and at endpoint during the 8 week treatment period ]

61.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week   [ Time Frame: 1 week ]

62.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks   [ Time Frame: 2 weeks ]

63.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks   [ Time Frame: 3 weeks ]

64.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks   [ Time Frame: 4 weeks ]

65.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks   [ Time Frame: 5 weeks ]

66.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks   [ Time Frame: 6 weeks ]

67.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks   [ Time Frame: 7 weeks ]

68.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks   [ Time Frame: 8 weeks ]

69.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period   [ Time Frame: at endpoint during the 8 week treatment period ]