Clinical trial NCT00266409: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Generalized Anxiety Disorder
Panic Disorder
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-12-16
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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)
timeFrame: 10 weeks
measure: 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)
timeFrame: 10 weeks
Secondary outcomes:
measure: Change From Baseline in the Total HAM-A Score After 1 Week
timeFrame: Baseline and 1 week
measure: Change From Baseline in the Total HAM-A Score After 2 Weeks
timeFrame: Baseline and 2 Weeks
measure: Change From Baseline in the Total HAM-A Score After 3 Weeks
timeFrame: Baseline and 3 weeks
measure: Change From Baseline in the Total HAM-A Score After 4 Weeks
timeFrame: Baseline and 4 weeks
measure: Change From Baseline in the Total HAM-A Score After 5 Weeks
timeFrame: Baseline and 5 weeks
measure: Change From Baseline in the Total HAM-A Score After 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in the Total HAM-A Score After 7 Weeks
timeFrame: Baseline and 7 weeks
measure: Change From Baseline in the Total HAM-A Score After 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period
timeFrame: Baseline and at endpoint during the 8 week treatment period
measure: Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week
timeFrame: 1 week
measure: Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks
timeFrame: 2 weeks
measure: Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks
timeFrame: 3 weeks
measure: Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks
timeFrame: 4 weeks
measure: Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks
timeFrame: 5 weeks
measure: Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks
timeFrame: 6 weeks
measure: Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks
timeFrame: 7 weeks
measure: Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks
timeFrame: 8 weeks
measure: Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period
timeFrame: at endpoint during the 8 week treatment period
measure: Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks
timeFrame: Baseline and 2 weeks
measure: Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks
timeFrame: Baseline and 4 weeks
measure: Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period
timeFrame: Baseline and at endpoint during the 8 week treatment period
measure: Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week
timeFrame: 1 week
measure: Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks
timeFrame: 2 weeks
measure: Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks
timeFrame: 3 weeks
measure: Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks
timeFrame: 4 weeks
measure: Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks
timeFrame: 5 weeks
measure: Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks
timeFrame: 6 weeks
measure: Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks
timeFrame: 7 weeks
measure: Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks
timeFrame: 8 weeks
measure: Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period
timeFrame: at endpoint during the 8 week treatment period
measure: Change From Baseline in HAM-A-insomnia Subscore After 1 Week
timeFrame: Baseline and 1 week
measure: Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks
timeFrame: Baseline and 2 weeks
measure: Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks
timeFrame: Baseline and 3 weeks
measure: Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks
timeFrame: Baseline and 4 weeks
measure: Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks
timeFrame: Baseline and 5 weeks
measure: Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks
timeFrame: Baseline and 7 weeks
measure: Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period
timeFrame: Baseline and at endpoint during the 8 week treatment period
measure: Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week
timeFrame: Baseline and 1 week
measure: Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks
timeFrame: Baseline and 2 weeks
measure: Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks
timeFrame: Baseline and 3 weeks
measure: Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks
timeFrame: Baseline and 4 weeks
measure: Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks
timeFrame: Baseline and 5 weeks
measure: Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks
timeFrame: Baseline and 7 weeks
measure: Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period
timeFrame: Baseline and at endpoint during the 8 week treatment period
measure: Change From Baseline in HAM-A-somatic Subscore After 1 Week
timeFrame: Baseline and 1 week
measure: Change From Baseline in HAM-A-somatic Subscore After 2 Weeks
timeFrame: Baseline and 2 weeks
measure: Change From Baseline in HAM-A-somatic Subscore After 3 Weeks
timeFrame: Baseline and 3 weeks
measure: Change From Baseline in HAM-A-somatic Subscore After 4 Weeks
timeFrame: Baseline and 4 weeks
measure: Change From Baseline in HAM-A-somatic Subscore After 5 Weeks
timeFrame: Baseline and 5 weeks
measure: Change From Baseline in HAM-A-somatic Subscore After 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in HAM-A-somatic Subscore After 7 Weeks
timeFrame: Baseline and 7 weeks
measure: Change From Baseline in HAM-A-somatic Subscore After 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period
timeFrame: Baseline and at endpoint during the 8 week treatment period
measure: Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week
timeFrame: 1 week
measure: Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks
timeFrame: 2 weeks
measure: Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks
timeFrame: 3 weeks
measure: Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks
timeFrame: 4 weeks
measure: Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks
timeFrame: 5 weeks
measure: Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks
timeFrame: 6 weeks
measure: Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks
timeFrame: 7 weeks
measure: Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks
timeFrame: 8 weeks
measure: Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period
timeFrame: at endpoint during the 8 week treatment period
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Schwarz
state: Wisconsin
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
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.
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.