Status:
COMPLETED
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
Lead Sponsor:
UCB Pharma
Conditions:
Generalized Anxiety Disorder
Panic Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 Inhibi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT00266409
Start Date
October 1 2005
End Date
June 1 2006
Last Update
October 27 2014
Active Locations (1)
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1
Schwarz
Milwaukee, Wisconsin, United States