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.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00266409
First received: December 15, 2005
Last updated: August 30, 2011
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Generalized Anxiety Disorder
Panic Disorder
Drug: Niravam
Drug: SSRI/SNRI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in the Total HAM-A Score After 1 Week [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Total HAM-A Score After 2 Weeks [ Time Frame: Baseline and 2 Weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Total HAM-A Score After 3 Weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Total HAM-A Score After 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Total HAM-A Score After 5 Weeks [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Total HAM-A Score After 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Total HAM-A Score After 7 Weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Total HAM-A Score After 8 Weeks [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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).

  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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).

  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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).

  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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).

  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    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).

  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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).

  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    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).

  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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).

  • Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect.

  • Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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).

  • Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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).

  • Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    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).

  • Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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).

  • Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    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).

  • Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-insomnia Subscore After 1 Week [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-somatic Subscore After 1 Week [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-somatic Subscore After 2 Weeks [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-somatic Subscore After 3 Weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-somatic Subscore After 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-somatic Subscore After 5 Weeks [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-somatic Subscore After 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-somatic Subscore After 7 Weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A-somatic Subscore After 8 Weeks [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Endpoint is last observed value during the 8 week treatment period.


Enrollment: 418
Study Start Date: October 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panic: Niravam+SSRI/SNRI
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Drug: Niravam
Other Name: Alprazolam
Drug: SSRI/SNRI
Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor
Experimental: Panic: SSRI/SNRI alone
Panic Disorder: Newly prescribed SSRI or SNRI alone
Drug: SSRI/SNRI
Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor
Experimental: GAD: Niravam+SSRI/SNRI
Generalized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI
Drug: Niravam
Other Name: Alprazolam
Drug: SSRI/SNRI
Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor
Experimental: GAD: SSRI/SNRI alone
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
Drug: SSRI/SNRI
Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266409

Locations
United States, Wisconsin
Schwarz
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Publications:
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, Inc.
ClinicalTrials.gov Identifier: NCT00266409     History of Changes
Other Study ID Numbers: SP851
Study First Received: December 15, 2005
Results First Received: May 5, 2009
Last Updated: August 30, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Panic Disorder
Mental Disorders
Alprazolam
Serotonin Uptake Inhibitors
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 20, 2014