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)

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)

3.  Secondary:

Change From Baseline in the Total HAM-A Score After 1 Week

4.  Secondary:

Change From Baseline in the Total HAM-A Score After 2 Weeks

5.  Secondary:

Change From Baseline in the Total HAM-A Score After 3 Weeks

6.  Secondary:

Change From Baseline in the Total HAM-A Score After 4 Weeks

7.  Secondary:

Change From Baseline in the Total HAM-A Score After 5 Weeks

8.  Secondary:

Change From Baseline in the Total HAM-A Score After 6 Weeks

9.  Secondary:

Change From Baseline in the Total HAM-A Score After 7 Weeks

10.  Secondary:

Change From Baseline in the Total HAM-A Score After 8 Weeks

11.  Secondary:

Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period

12.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week

13.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks

14.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks

15.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks

16.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks

17.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks

18.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks

19.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks

20.  Secondary:

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) 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

22.  Secondary:

Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks

23.  Secondary:

Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 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

25.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week

26.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks

27.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks

28.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks

29.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks

30.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks

31.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks

32.  Secondary:

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 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

34.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 1 Week

35.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks

36.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks

37.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks

38.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks

39.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks

40.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks

41.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks

42.  Secondary:

Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period

43.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week

44.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks

45.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks

46.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks

47.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks

48.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks

49.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks

50.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks

51.  Secondary:

Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period

52.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 1 Week

53.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 2 Weeks

54.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 3 Weeks

55.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 4 Weeks

56.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 5 Weeks

57.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 6 Weeks

58.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 7 Weeks

59.  Secondary:

Change From Baseline in HAM-A-somatic Subscore After 8 Weeks

60.  Secondary:

Change From Baseline in HAM-A-somatic Subscore 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

62.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks

63.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks

64.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks

65.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks

66.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks

67.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks

68.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks

69.  Secondary:

Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period