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
Condition: Generalized Anxiety Disorder; Panic Disorder
MeSH terms: Anxiety Disorders; Panic Disorder
Intervention: Niravam; SSRI/SNRI
Intervention description: Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor
Intervention MeSH terms: Alprazolam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 418.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.