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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
This study has been completed.
Study NCT00266409   Information provided by UCB, Inc.
First Received: December 15, 2005   Last Updated: November 5, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Open Label, Parallel Assignment
Conditions: Generalized Anxiety Disorder
Panic Disorder
Interventions: Drug: Niravam
Drug: SSRI/SNRI

  Participant Flow
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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  



  Baseline Characteristics
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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



  Outcome Measures
  Show All Outcome Measures

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)   [ 10 weeks ]
  Show Outcome Measure 1

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)   [ 10 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in the Total HAM-A Score After 1 Week   [ Baseline and 1 week ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in the Total HAM-A Score After 2 Weeks   [ Baseline and 2 Weeks ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in the Total HAM-A Score After 3 Weeks   [ Baseline and 3 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in the Total HAM-A Score After 4 Weeks   [ Baseline and 4 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in the Total HAM-A Score After 5 Weeks   [ Baseline and 5 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in the Total HAM-A Score After 6 Weeks   [ Baseline and 6 weeks ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in the Total HAM-A Score After 7 Weeks   [ Baseline and 7 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline in the Total HAM-A Score After 8 Weeks   [ Baseline and 8 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period   [ Baseline and at endpoint during the 8 week treatment period ]
  Show Outcome Measure 11

12.  Secondary:   Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week   [ 1 week ]
  Show Outcome Measure 12

13.  Secondary:   Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks   [ 2 weeks ]
  Show Outcome Measure 13

14.  Secondary:   Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks   [ 3 weeks ]
  Show Outcome Measure 14

15.  Secondary:   Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks   [ 4 weeks ]
  Show Outcome Measure 15

16.  Secondary:   Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks   [ 5 weeks ]
  Show Outcome Measure 16

17.  Secondary:   Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks   [ 6 weeks ]
  Show Outcome Measure 17

18.  Secondary:   Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks   [ 7 weeks ]
  Show Outcome Measure 18

19.  Secondary:   Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks   [ 8 weeks ]
  Show Outcome Measure 19

20.  Secondary:   Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period   [ at endpoint during the 8 week treatment period ]
  Show Outcome Measure 20

21.  Secondary:   Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks   [ Baseline and 2 weeks ]
  Show Outcome Measure 21

22.  Secondary:   Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks   [ Baseline and 4 weeks ]
  Show Outcome Measure 22

23.  Secondary:   Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks   [ Baseline and 8 weeks ]
  Hide Outcome Measure 23

Measure Type Secondary
Measure Title Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
Measure Description 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).
Time Frame Baseline and 8 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

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

Measured Values
  Panic: Niravam+SSRI/SNRI Panic: SSRI/SNRI Alone GAD : Niravam+SSRI/SNRI GAD: SSRI/SNRI Alone
Number of Participants Analyzed
[units: participants] 		93 96 57 51
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
[units: participants]
 		       
Very much improved 28 27 14 12
Much improved 44 27 25 22
Minimally improved 16 19 11 13
No change 3 19 5 4
Minimally worse 2 1 1 0
Much worse 0 2 1 0
Very much worse 0 1 0 0


Statistical Analysis 1 for Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
Groups [1] Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method [2] van Elteren test
P Value [3] 0.0370
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
Groups [1] GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method [2] van Elteren test
P Value [3] 0.9569
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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   [ Baseline and at endpoint during the 8 week treatment period ]
  Show Outcome Measure 24

25.  Secondary:   Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week   [ 1 week ]
  Show Outcome Measure 25

26.  Secondary:   Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks   [ 2 weeks ]
  Show Outcome Measure 26

27.  Secondary:   Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks   [ 3 weeks ]
  Show Outcome Measure 27

28.  Secondary:   Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks   [ 4 weeks ]
  Show Outcome Measure 28

29.  Secondary:   Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks   [ 5 weeks ]
  Show Outcome Measure 29

30.  Secondary:   Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks   [ 6 weeks ]
  Show Outcome Measure 30

31.  Secondary:   Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks   [ 7 weeks ]
  Show Outcome Measure 31

32.  Secondary:   Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks   [ 8 weeks ]
  Show Outcome Measure 32

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   [ at endpoint during the 8 week treatment period ]
  Show Outcome Measure 33

34.  Secondary:   Change From Baseline in HAM-A-insomnia Subscore After 1 Week   [ Baseline and 1 week ]
  Show Outcome Measure 34

35.  Secondary:   Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks   [ Baseline and 2 weeks ]
  Show Outcome Measure 35

36.  Secondary:   Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks   [ Baseline and 3 weeks ]
  Show Outcome Measure 36

37.  Secondary:   Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks   [ Baseline and 4 weeks ]
  Show Outcome Measure 37

38.  Secondary:   Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks   [ Baseline and 5 weeks ]
  Show Outcome Measure 38

39.  Secondary:   Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks   [ Baseline and 6 weeks ]
  Show Outcome Measure 39

40.  Secondary:   Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks   [ Baseline and 7 weeks ]
  Show Outcome Measure 40

41.  Secondary:   Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks   [ Baseline and 8 weeks ]
  Show Outcome Measure 41

42.  Secondary:   Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period   [ Baseline and at endpoint during the 8 week treatment period ]
  Show Outcome Measure 42

43.  Secondary:   Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week   [ Baseline and 1 week ]
  Show Outcome Measure 43

44.  Secondary:   Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks   [ Baseline and 2 weeks ]
  Show Outcome Measure 44

45.  Secondary:   Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks   [ Baseline and 3 weeks ]
  Show Outcome Measure 45

46.  Secondary:   Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks   [ Baseline and 4 weeks ]
  Show Outcome Measure 46

47.  Secondary:   Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks   [ Baseline and 5 weeks ]
  Show Outcome Measure 47

48.  Secondary:   Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks   [ Baseline and 6 weeks ]
  Show Outcome Measure 48

49.  Secondary:   Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks   [ Baseline and 7 weeks ]
  Show Outcome Measure 49

50.  Secondary:   Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks   [ Baseline and 8 weeks ]
  Show Outcome Measure 50

51.  Secondary:   Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period   [ Baseline and at endpoint during the 8 week treatment period ]
  Show Outcome Measure 51

52.  Secondary:   Change From Baseline in HAM-A-somatic Subscore After 1 Week   [ Baseline and 1 week ]
  Show Outcome Measure 52

53.  Secondary:   Change From Baseline in HAM-A-somatic Subscore After 2 Weeks   [ Baseline and 2 weeks ]
  Show Outcome Measure 53

54.  Secondary:   Change From Baseline in HAM-A-somatic Subscore After 3 Weeks   [ Baseline and 3 weeks ]
  Show Outcome Measure 54

55.  Secondary:   Change From Baseline in HAM-A-somatic Subscore After 4 Weeks   [ Baseline and 4 weeks ]
  Show Outcome Measure 55

56.  Secondary:   Change From Baseline in HAM-A-somatic Subscore After 5 Weeks   [ Baseline and 5 weeks ]
  Show Outcome Measure 56

57.  Secondary:   Change From Baseline in HAM-A-somatic Subscore After 6 Weeks   [ Baseline and 6 weeks ]
  Show Outcome Measure 57

58.  Secondary:   Change From Baseline in HAM-A-somatic Subscore After 7 Weeks   [ Baseline and 7 weeks ]
  Show Outcome Measure 58

59.  Secondary:   Change From Baseline in HAM-A-somatic Subscore After 8 Weeks   [ Baseline and 8 weeks ]
  Show Outcome Measure 59

60.  Secondary:   Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period   [ Baseline and at endpoint during the 8 week treatment period ]
  Show Outcome Measure 60

61.  Secondary:   Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week   [ 1 week ]
  Show Outcome Measure 61

62.  Secondary:   Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks   [ 2 weeks ]
  Show Outcome Measure 62

63.  Secondary:   Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks   [ 3 weeks ]
  Show Outcome Measure 63

64.  Secondary:   Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks   [ 4 weeks ]
  Show Outcome Measure 64

65.  Secondary:   Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks   [ 5 weeks ]
  Show Outcome Measure 65

66.  Secondary:   Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks   [ 6 weeks ]
  Show Outcome Measure 66

67.  Secondary:   Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks   [ 7 weeks ]
  Show Outcome Measure 67

68.  Secondary:   Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks   [ 8 weeks ]
  Show Outcome Measure 68

69.  Secondary:   Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period   [ at endpoint during the 8 week treatment period ]
  Show Outcome Measure 69


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Originally it was planned to enrol and randomize 848 subjects. The smaller than planned sample size was a result of an unusually high rate of screening failure (results published in Psychiatry 2006, Vol. 3, Issue 12 , pages 39 - 59).  


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
phone: +1 877 822 9493


Publications of Results:
Katzelnick DM, Saidi J, Vanelli MR, Jefferson JW, Harper JM, McCrary KE. Time to Response in Panic Disorder in a Naturalistic Setting: Combination Therapy with Alprazolam Orally Disintegrating Tablets and Serotonin Reuptake Inhibitors Compared to Serotonin Reuptake Inhibitors Alone. Psychiatry 3(12): 39-49, 2006
Rapaport MH, Skarky SB, Katzelnick DJ, DeWester JN, Harper JM, McCrary K. Time to Response in Generalized Anxiety Disorder in a Naturalistic Setting: Combination Therapy with Alprazolam Orally Disintegrating Tablets and Serotonin Reuptake Inhibitors Compared to Serotonin Reuptake Inhibitors alone. Psychiatry 3(12): 50-59, 2006


Responsible Party: UCB ( Study Director )
Study ID Numbers: SP851
Study First Received: December 15, 2005
Results First Received: May 5, 2009
Last Updated: November 5, 2009
ClinicalTrials.gov Identifier: NCT00266409     History of Changes
Health Authority: United States: Institutional Review Board





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