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

UCB

Status and phase: Completed; Phase 4

Conditions: Panic Disorder; Generalized Anxiety Disorder

Treatments: Drug: Niravam; Drug: SSRI/SNRI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00266409

SP0851

Details and patient eligibility

About

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.

Enrollment: 418 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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418 participants in 4 patient groups

Panic: Niravam+SSRI/SNRI

Experimental group

Description:

Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI

Treatment:

Drug: SSRI/SNRI

Drug: Niravam

Panic: SSRI/SNRI alone

Experimental group

Description:

Panic Disorder: Newly prescribed SSRI or SNRI alone

Treatment:

Drug: SSRI/SNRI

GAD: Niravam+SSRI/SNRI

Experimental group

Description:

Generalized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI

Treatment:

Drug: SSRI/SNRI

Drug: Niravam

GAD: SSRI/SNRI alone

Experimental group

Description:

Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Treatment:

Drug: SSRI/SNRI