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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

Primary Purpose

Generalized Anxiety Disorder, Panic Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Niravam
SSRI/SNRI
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Schwarz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Panic: Niravam+SSRI/SNRI

Panic: SSRI/SNRI alone

GAD: Niravam+SSRI/SNRI

GAD: SSRI/SNRI alone

Arm Description

Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI

Panic Disorder: Newly prescribed SSRI or SNRI alone

Generalized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI

Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Outcomes

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)
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 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.

Full Information

First Posted
December 15, 2005
Last Updated
October 17, 2014
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00266409
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Panic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
418 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Panic: Niravam+SSRI/SNRI
Arm Type
Experimental
Arm Description
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Arm Title
Panic: SSRI/SNRI alone
Arm Type
Experimental
Arm Description
Panic Disorder: Newly prescribed SSRI or SNRI alone
Arm Title
GAD: Niravam+SSRI/SNRI
Arm Type
Experimental
Arm Description
Generalized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI
Arm Title
GAD: SSRI/SNRI alone
Arm Type
Experimental
Arm Description
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
Intervention Type
Drug
Intervention Name(s)
Niravam
Other Intervention Name(s)
Alprazolam
Intervention Type
Drug
Intervention Name(s)
SSRI/SNRI
Intervention Description
Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
10 weeks
Title
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)
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in the Total HAM-A Score After 1 Week
Description
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.
Time Frame
Baseline and 1 week
Title
Change From Baseline in the Total HAM-A Score After 2 Weeks
Description
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.
Time Frame
Baseline and 2 Weeks
Title
Change From Baseline in the Total HAM-A Score After 3 Weeks
Description
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.
Time Frame
Baseline and 3 weeks
Title
Change From Baseline in the Total HAM-A Score After 4 Weeks
Description
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.
Time Frame
Baseline and 4 weeks
Title
Change From Baseline in the Total HAM-A Score After 5 Weeks
Description
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.
Time Frame
Baseline and 5 weeks
Title
Change From Baseline in the Total HAM-A Score After 6 Weeks
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in the Total HAM-A Score After 7 Weeks
Description
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.
Time Frame
Baseline and 7 weeks
Title
Change From Baseline in the Total HAM-A Score After 8 Weeks
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period
Description
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.
Time Frame
Baseline and at endpoint during the 8 week treatment period
Title
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week
Description
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).
Time Frame
1 week
Title
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks
Description
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).
Time Frame
2 weeks
Title
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks
Description
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).
Time Frame
3 weeks
Title
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks
Description
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).
Time Frame
4 weeks
Title
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks
Description
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).
Time Frame
5 weeks
Title
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks
Description
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).
Time Frame
6 weeks
Title
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks
Description
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).
Time Frame
7 weeks
Title
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks
Description
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).
Time Frame
8 weeks
Title
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period
Description
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.
Time Frame
at endpoint during the 8 week treatment period
Title
Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks
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 2 weeks
Title
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks
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 4 weeks
Title
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
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
Title
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period
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). Endpoint is last observed value during the 8 week treatment period.
Time Frame
Baseline and at endpoint during the 8 week treatment period
Title
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week
Description
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).
Time Frame
1 week
Title
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks
Description
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect.
Time Frame
2 weeks
Title
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks
Description
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).
Time Frame
3 weeks
Title
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks
Description
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).
Time Frame
4 weeks
Title
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks
Description
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).
Time Frame
5 weeks
Title
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks
Description
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).
Time Frame
6 weeks
Title
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks
Description
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).
Time Frame
7 weeks
Title
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks
Description
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).
Time Frame
8 weeks
Title
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period
Description
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.
Time Frame
at endpoint during the 8 week treatment period
Title
Change From Baseline in HAM-A-insomnia Subscore After 1 Week
Description
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.
Time Frame
Baseline and 1 week
Title
Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks
Description
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.
Time Frame
Baseline and 2 weeks
Title
Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks
Description
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.
Time Frame
Baseline and 3 weeks
Title
Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks
Description
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.
Time Frame
Baseline and 4 weeks
Title
Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks
Description
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.
Time Frame
Baseline and 5 weeks
Title
Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks
Description
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.
Time Frame
Baseline and 7 weeks
Title
Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period
Description
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.
Time Frame
Baseline and at endpoint during the 8 week treatment period
Title
Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week
Description
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.
Time Frame
Baseline and 1 week
Title
Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks
Description
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.
Time Frame
Baseline and 2 weeks
Title
Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks
Description
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.
Time Frame
Baseline and 3 weeks
Title
Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks
Description
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.
Time Frame
Baseline and 4 weeks
Title
Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks
Description
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.
Time Frame
Baseline and 5 weeks
Title
Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks
Description
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.
Time Frame
Baseline and 7 weeks
Title
Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period
Description
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.
Time Frame
Baseline and at endpoint during the 8 week treatment period
Title
Change From Baseline in HAM-A-somatic Subscore After 1 Week
Description
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.
Time Frame
Baseline and 1 week
Title
Change From Baseline in HAM-A-somatic Subscore After 2 Weeks
Description
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.
Time Frame
Baseline and 2 weeks
Title
Change From Baseline in HAM-A-somatic Subscore After 3 Weeks
Description
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.
Time Frame
Baseline and 3 weeks
Title
Change From Baseline in HAM-A-somatic Subscore After 4 Weeks
Description
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.
Time Frame
Baseline and 4 weeks
Title
Change From Baseline in HAM-A-somatic Subscore After 5 Weeks
Description
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.
Time Frame
Baseline and 5 weeks
Title
Change From Baseline in HAM-A-somatic Subscore After 6 Weeks
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in HAM-A-somatic Subscore After 7 Weeks
Description
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.
Time Frame
Baseline and 7 weeks
Title
Change From Baseline in HAM-A-somatic Subscore After 8 Weeks
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period
Description
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.
Time Frame
Baseline and at endpoint during the 8 week treatment period
Title
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week
Time Frame
1 week
Title
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks
Time Frame
2 weeks
Title
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks
Time Frame
3 weeks
Title
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks
Time Frame
4 weeks
Title
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks
Time Frame
5 weeks
Title
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks
Time Frame
6 weeks
Title
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks
Time Frame
7 weeks
Title
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks
Time Frame
8 weeks
Title
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period
Description
Endpoint is last observed value during the 8 week treatment period.
Time Frame
at endpoint during the 8 week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Schwarz
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20877555
Citation
Katzelnick DJ, 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 (Edgmont). 2006 Dec;3(12):39-49.
Results Reference
result
PubMed Identifier
20877556
Citation
Rapaport MH, Skarky SB, Katzelnick DJ, Dewester JN, Harper JM, McCrary KE. 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 (Edgmont). 2006 Dec;3(12):50-9.
Results Reference
result
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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