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Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder
This study has been completed.
First Received: December 15, 2005   Last Updated: November 5, 2009   History of Changes
Sponsor: UCB, Inc.
Information provided by: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00266409
  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 IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Anxiety Panic Disorder
Drug Information available for: Serotonin Alprazolam
U.S. FDA Resources

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 ]
  • 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 ]

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 ]
  • Change From Baseline in the Total HAM-A Score After 2 Weeks [ Time Frame: Baseline and 2 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in the Total HAM-A Score After 3 Weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in the Total HAM-A Score After 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in the Total HAM-A Score After 5 Weeks [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in the Total HAM-A Score After 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in the Total HAM-A Score After 7 Weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in the Total HAM-A Score After 8 Weeks [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • 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 ]
  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change From Baseline in HAM-A-insomnia Subscore After 1 Week [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • 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 ]
  • Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • 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 ]
  • Change From Baseline in HAM-A-somatic Subscore After 1 Week [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-somatic Subscore After 2 Weeks [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-somatic Subscore After 3 Weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-somatic Subscore After 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-somatic Subscore After 5 Weeks [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-somatic Subscore After 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-somatic Subscore After 7 Weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A-somatic Subscore After 8 Weeks [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 ]

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
Panic: Niravam+SSRI/SNRI: Experimental
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Drug: Niravam Drug: SSRI/SNRI
Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor
Panic: SSRI/SNRI alone: Experimental
Panic Disorder: Newly prescribed SSRI or SNRI alone
Drug: SSRI/SNRI
Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor
GAD: Niravam+SSRI/SNRI: Experimental
Generalized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI
Drug: Niravam Drug: SSRI/SNRI
Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor
GAD: SSRI/SNRI alone: Experimental
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
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

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

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

ClinicalTrials.gov processed this record on November 25, 2009



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