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
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Keep this study
Lead
UCB Pharma
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 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
