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

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

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder; Panic Disorder
• Intervention / Treatment: Drug: Niravam; Drug: SSRI/SNRI

• Study Type: Interventional
• Enrollment (Actual): 418
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States
      • Schwarz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panic: Niravam+SSRI/SNRI; Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI	Drug: Niravam; Other Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 weeks
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.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 1 week
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.	Baseline and 2 Weeks
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.	Baseline and 3 weeks
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.	Baseline and 4 weeks
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.	Baseline and 5 weeks
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.	Baseline and 6 weeks
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.	Baseline and 7 weeks
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.	Baseline and 8 weeks
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.	Baseline and at endpoint 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).	1 week
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).	2 weeks
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).	3 weeks
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).	4 weeks
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).	5 weeks
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).	6 weeks
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).	7 weeks
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).	8 weeks
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.	at endpoint 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).	Baseline and 2 weeks
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).	Baseline and 4 weeks
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).	Baseline and 8 weeks
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.	Baseline and at endpoint 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).	1 week
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.	2 weeks
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).	3 weeks
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).	4 weeks
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).	5 weeks
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).	6 weeks
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).	7 weeks
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).	8 weeks
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.	at endpoint 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.	Baseline and 1 week
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.	Baseline and 2 weeks
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.	Baseline and 3 weeks
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.	Baseline and 4 weeks
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.	Baseline and 5 weeks
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.	Baseline and 6 weeks
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.	Baseline and 7 weeks
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.	Baseline and 8 weeks
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.	Baseline and at endpoint 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.	Baseline and 1 week
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.	Baseline and 2 weeks
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.	Baseline and 3 weeks
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.	Baseline and 4 weeks
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.	Baseline and 5 weeks
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.	Baseline and 6 weeks
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.	Baseline and 7 weeks
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.	Baseline and 8 weeks
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.	Baseline and at endpoint 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.	Baseline and 1 week
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.	Baseline and 2 weeks
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.	Baseline and 3 weeks
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.	Baseline and 4 weeks
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.	Baseline and 5 weeks
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.	Baseline and 6 weeks
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.	Baseline and 7 weeks
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.	Baseline and 8 weeks
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.	Baseline and at endpoint during the 8 week treatment period
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week		1 week
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks		2 weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks		3 weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks		4 weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks		5 weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks		6 weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks		7 weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks		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.	at endpoint during the 8 week treatment period

Collaborators and Investigators

• Sponsor: UCB Pharma

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: December 15, 2005
• First Submitted That Met QC Criteria: December 15, 2005
• First Posted (Estimate): December 16, 2005

Study Record Updates

• Last Update Posted (Estimate): October 27, 2014
• Last Update Submitted That Met QC Criteria: October 17, 2014
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders; Panic Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Alprazolam
• Other Study ID Numbers: SP0851